FDA 510(k) Applications Submitted by DAVID W SCHLERF

FDA 510(k) Number Submission Date Device Name Applicant
K860131 01/14/1986 ACROMED SPINAL SURGERY INSTRUMENTS BUCKMAN CO., INC.
K931555 03/30/1993 ARTROMOT K2 CPM ORMED MFG., INC.
K041621 06/16/2004 LITEPORT LP100 SURGICAL ILLUMINATOR MEDICAL VISION INDUSTRIES, INC.
K922935 06/18/1992 CONBIO-MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM BUCKMAN CO., INC.
K923857 07/31/1992 ARTROMOT SB ELBOW ATTACHMENT BUCKMAN CO., INC.
K895079 08/14/1989 ACE BEADED K-WIRES ACE OLIVE WIRES BUCKMAN CO., INC.
K895107 08/15/1989 ACE ORTHOPAEDIC WASHERS BUCKMAN CO., INC.
K072326 08/20/2007 OSTAPEK VBR SYSTEM CO-LIGNE AG
K873684 09/14/1987 ACE INTRA COMPARTMENTAL PRESSURE MONITOR ACE MEDICAL CO.
K904505 10/02/1990 CCI CORNEAL SCARIFIER BUCKMAN CO., INC.
K864340 11/04/1986 WILLIAMS ORTHOPAEDIC SURGICAL INSTRUMENTS BUCKMAN CO., INC.
K875223 12/22/1987 DANNINGER ORTHOPAEDIC AWL DANNINGER MEDICAL TECHNOLOGY, INC.
K913026 07/09/1991 TTU-100THERMAL THERAPY UNIT DANNINGER MEDICAL TECHNOLOGY, INC.
K032086 07/07/2003 KRYO ART CONTROLLED RATE FREEZER PLANER PLC
K860017 01/03/1986 ACROMED CANCELLOUS BONE SCREW BUCKMAN CO., INC.
K860018 01/03/1986 FISCHER WIRE/PIN CLAMP BUCKMAN CO., INC.
K000003 01/03/2000 TORNIER TOTAL ELBOW PROSTHESIS TORNIER
K880045 01/06/1988 ACROMED AWL/PUNCH, DEPTH GAUGE BUCKMAN CO., INC.
K880046 01/06/1988 HASTING FINGER FIXATOR INSTRUMENTS BUCKMAN CO., INC.
K950099 01/10/1995 SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM BUCKMAN CO., INC.
K920116 01/13/1992 PWB LUMBOSACRAL SPINE SYSTEM CROSS MEDICAL PRODUCTS, INC.
K920117 01/13/1992 HALO ESPRIT ITM CORP.
K850142 01/14/1985 ACE INTRAMEDULLARY ROD FOR SMALL BONES BUCKMAN CO., INC.
K900264 01/18/1990 R-BAND(TM) RESPIRATORY SENSOR BUCKMAN CO., INC.
K990153 01/19/1999 VIRGO MRI SYSTEM MILLENNIUM TECHNOLOGY SERVICES
K950248 01/20/1995 LASERSPRAY(TM) BIOLASE TECHNOLOGY, INC.
K980237 01/23/1998 GYNEX ENDOSPECULUM GYNEX CORP.
K980238 01/23/1998 GYNEX EXTENDED REACH NEEDLE GYNEX CORP.
K980244 01/23/1998 AEQUALIS SHOULDER PROSTHESIS TORNIER
K980247 01/23/1998 GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM GYNEX CORP.
K860246 01/24/1986 "ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE" BUCKMAN CO., INC.
K960451 01/30/1996 WEBB-MORLEY SPINE SYSTEM BUCKMAN CO., INC.
K930515 02/01/1993 ALPHA SPINAL SYSTEM ALPHATEC MFG., INC.
K930531 02/02/1993 AME(R) RIGID FIXATION SYSTEM AMERICAN MEDICAL ELECTRONICS, INC.
K870404 02/03/1987 COLORED CASTING TAPE (RED AND BLUE) BUCKMAN CO., INC.
K870510 02/05/1987 DANNIFLEX 400I BUCKMAN CO., INC.
K990363 02/05/1999 BIOMESH BIODEGRADABLE GTR BARRIER SAMYANG CORP.
K900581 02/07/1990 DANNIFLEX CPM 880(TM) BUCKMAN CO., INC.
K930634 02/08/1993 SUR FLO THERMAL THERAPY PADS BUCKMAN CO., INC.
K870578 02/10/1987 NIGHTWATCH(TM) SYSTEM BUCKMAN CO., INC.
K890722 02/13/1989 ADG BONE BIOPSY SYSTEM AMERICAN DESIGN GROUP, INC.
K950709 02/13/1995 SYNERGY TI ANTERIOR SPINAL SYSTEM CROSS MEDICAL PRODUCTS, INC.
K940631 02/14/1994 CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM CROSS MEDICAL PRODUCTS, INC.
K040401 02/17/2004 LANX ANTERIOR CERVIAL PLATE SYSTEM LANX, LLC
K860590 02/19/1986 ACE UNILATERAL FIXATOR BUCKMAN CO., INC.
K860591 02/19/1986 ACE MULTIPLE PIN PLATE BUCKMAN CO., INC.
K860592 02/19/1986 ACE IM ROD BUCKMAN CO., INC.
K870702 02/20/1987 ADG PATELLAR COMPONENT BUCKMAN CO., INC.
K860714 02/26/1986 ACE AIM - CPM HAND UNIT BUCKMAN CO., INC.
K870778 02/26/1987 ACROMED WALLIE-HEINIG CURETTES BUCKMAN CO., INC.
K870779 02/26/1987 ACROMED WALLIE-HEINIG TROCHAR BUCKMAN CO., INC.
K870780 02/26/1987 ACROMED WALLIE-HEINIG OSTEOTOMES BUCKMAN CO., INC.
K870781 02/26/1987 ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS BUCKMAN CO., INC.
K950999 03/03/1995 KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS BUCKMAN CO., INC.
K921056 03/05/1992 COTREL - DUBOUSSET SPINE IMPLANTS BUCKMAN CO., INC.
K931128 03/05/1993 BASIC SHOULDER CPM DANNINGER MEDICAL TECHNOLOGY, INC.
K970829 03/06/1997 PHUSIS ABSORBABLE INTERFERENCE SCREW TORNIER
K880963 03/08/1988 HAC "AUTOLOGY CENTERS" DISPENSING KIT FOR FIB.CON. BUCKMAN CO., INC.
K951117 03/10/1995 LIHTAN 532 LASER BUCKMAN CO., INC.
K020791 03/11/2002 HBS HEADLESS BONE SCREW MILLENNIUM MEDICAL TECHNOLOGIES, INC.
K010727 03/12/2001 FLEXLINE CLAMP NOVARE SURGICAL SYSTEMS, INC.
K891405 03/14/1989 BMS-2000 MOBILE EEG SYSTEM BUCKMAN CO., INC.
K970968 03/17/1997 BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS GUENTER BISSINGER MEDIZINTECHNIK GMBH
K881250 03/23/1988 ACE PNEUMATIC OSCILLATING SAW BUCKMAN CO., INC.
K931488 03/25/1993 KSF SPINAL FIXATOR FRANKLIN MEDICAL USA, INC.
K050774 03/25/2005 LANX ANTERIOR CERVICAL PLATE SYSTEM LANX, LLC
K861136 03/26/1986 INTERSTIM 100 SYSTEM BUCKMAN CO., INC.
K031050 04/02/2003 PCW PERCUTANEOUS COMPRESSION WIRE MILLENNIUM MEDICAL TECHNOLOGIES, INC.
K971272 04/04/1997 TRAUMA-FIX EXTERNAL FIXATOR TREND MEDICAL, INC.
K961320 04/05/1996 CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM BUCKMAN CO., INC.
K921686 04/08/1992 ENDOMED LAPAROSCOPY INSTRUMENTS BUCKMAN CO., INC.
K931778 04/09/1993 LAPAROSCOPY INSTRUMENTS BUCKMAN CO., INC.
K901677 04/10/1990 CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER BUCKMAN CO., INC.
K011142 04/13/2001 AQUARIUS WORKSTATION TERARECON, INC.
K921767 04/14/1992 COMPACT COTREL -- DUBOUSSET SPINE SYSTEM BUCKMAN CO., INC.
K911717 04/17/1991 ADG INTRAMEDULLARY BONE PLUG - VENTED AMERICAN DESIGN GROUP, INC.
K881699 04/19/1988 ACROMED WASHERS BUCKMAN CO., INC.
K871539 04/20/1987 ZINDRICK IM ROD BUCKMAN CO., INC.
K951846 04/20/1995 MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS ALPHATEC MFG., INC.
K881717 04/21/1988 PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) BUCKMAN CO., INC.
K051089 04/28/2005 GII SPINAL FIXATION SYSTEM CO-LIGNE AG
K881841 05/02/1988 DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS BUCKMAN CO., INC.
K901984 05/02/1990 ACE WIRE TENSION CLAMP BUCKMAN CO., INC.
K881858 05/03/1988 ACE ICPM SIDE PORTED NEEDLE BUCKMAN CO., INC.
K882008 05/13/1988 ACE SCREW REMOVAL TREPHINE BUCKMAN CO., INC.
K882034 05/16/1988 INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER BUCKMAN CO., INC.
K882035 05/16/1988 HEART-CHILL SALINE SLUSH PAD BUCKMAN CO., INC.
K882036 05/16/1988 WILLIAMS ACS MARKER NEEDLE BUCKMAN CO., INC.
K971821 05/16/1997 UNICA 315 M CO2 SURGICAL LASER SYSTEM RELIANT TECHNOLOGIES, INC.
K021623 05/16/2002 UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS IAME, INC.
K001535 05/17/2000 ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION ORTHOTEC, L.L.C.
K952489 05/30/1995 6 WATT HOLMIUM LASER SYSTEM NEW STAR LASERS, INC.
K922577 06/01/1992 CONBIO-MEDLITE(TM) Q-SWITCHED ND:YAG LASER SYSTEM CONTINUUM BIOMEDICAL, INC.
K882322 06/06/1988 CONTINUUM KNEE SYSTEM (CKS) BUCKMAN CO., INC.
K942729 06/09/1994 LIHTAN 4100 KRYPTON LIHTAN TECHNOLOGIES, INC.
K942751 06/10/1994 VANGUARD SERIES GAS REGULATORS BUCKMAN CO., INC.
K882443 06/14/1988 ZINDRICK IM ROD INSTRUMENTS BUCKMAN CO., INC.
K922901 06/16/1992 INCISOR I PULSED ND:YAG LASER SYSTEM BUCKMAN CO., INC.
K922919 06/17/1992 DYNACYT BIOPSY ASPIRATION DEVICE BUCKMAN CO., INC.
K882605 06/24/1988 EURO-MED "CLEAR-VUE" DISPOSABLE VAGINAL SPECULUM BUCKMAN CO., INC.
K882606 06/24/1988 EURO-MED "ENDO-CURETTE" BUCKMAN CO., INC.
K952928 06/26/1995 AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS TORNIER
K001932 06/26/2000 TORNIER CEMENT RESTRICTOR TORNIER
K862504 07/01/1986 ACE MOS SAW AND THE ACE MOS SPINE SAW BUCKMAN CO., INC.
K923216 07/01/1992 DANNINFLEX CPM 800 BUCKMAN CO., INC.
K923217 07/01/1992 DANNIFLEX CPM 2000 BUCKMAN CO., INC.
K862552 07/03/1986 ACROMED ADS BONE NAIL BUCKMAN CO., INC.
K012086 07/03/2001 AQUARIUSNET SERVER TERARECON, INC.
K912931 07/05/1991 ITM SONIC SURGERY SYSTEM BUCKMAN CO., INC.
K962631 07/05/1996 DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM FAIR IMAGE, INC.
K882831 07/08/1988 ACE CANCELLOUS BONE SCREW BUCKMAN CO., INC.
K933394 07/12/1993 DANNIFLEX CPM 600 DANNINGER MEDICAL TECHNOLOGY, INC.
K992384 07/16/1999 CPAP/PRO CPAP INTERFACE STEVENSON INDUSTRIES, INC.
K012294 07/20/2001 WRISTORE FIXATOR MILLENNIUM MEDICAL TECHNOLOGIES, INC.
K872858 07/21/1987 WILLIAMS VERTEBRAL SPREADER ACE MEDICAL CO.
K872859 07/21/1987 ACE CANCELLOUS BONE SCREW ACE MEDICAL CO.
K872949 07/28/1987 ACROMED BONE PLATE BENDER BUCKMAN CO., INC.
K883294 08/04/1988 SYNTHETIC CAST TAPE CARAPACE, INC.
K873066 08/05/1987 ACROMED SCREW DRIVER BUCKMAN CO., INC.
K873067 08/05/1987 ACROMED BONE SCREW TAP SLEEVES BUCKMAN CO., INC.
K982739 08/06/1998 GYNEX ELECTRODES GYNEX CORP.
K894982 08/08/1989 ACE WIRE TENSION CLAMP BUCKMAN CO., INC.
K895015 08/08/1989 ARTROMOT(TM) CPM DEVICES BUCKMAN CO., INC.
K873191 08/13/1987 ACROMED INTERBODY DEPTH GAUGES BUCKMAN CO., INC.
K022709 08/14/2002 MEDLITE Q-SWITHCED LASER CONTINUUM ELECTRO-OPTICS, INC.
K924142 08/17/1992 CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT CODMAN & SHURTLEFF, INC.
K953872 08/17/1995 SECOND EAR BONE CONDUCTION HEARING AID WORDCOMP INTERNATIONAL COMMUNICATION GROUP (WICG)
K903810 08/20/1990 ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW ACE MEDICAL CO.
K903811 08/20/1990 ACE CANNULATED CORTICAL BONE SCREW ACE MEDICAL CO.
K032589 08/22/2003 ENCLOSE II ANASTOMOSIS ASSIST DEVICE NOVARE SURGICAL SYSTEMS, INC.
K052384 08/30/2005 LANX VBR SYSTEM LANX, LLC
K924381 08/31/1992 PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS CROSS MEDICAL PRODUCTS, INC.
K924484 09/03/1992 ARTROMOT MULTI DIRECTIONAL ANKLE CPM BUCKMAN CO., INC.
K914004 09/06/1991 ALPHATEC CANNULATED BONE SCREWS ALPHATEC MFG., INC.
K973453 09/11/1997 TORNIER CEMENT RESTRICTOR TORNIER
K002824 09/11/2000 MACS MODULAR ANTERIOR CONSTRUCT SYSTEM AESCULAP, INC.
K934429 09/13/1993 ANTERIOR SPINE SYSTEM BUCKMAN CO., INC.
K873826 09/23/1987 ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION ACROMED CORP.
K983353 09/23/1998 SCS SPINAL SYSTEM ORTHOTEC, INC.
K873924 09/25/1987 PTI HEART-CHILL POUCH/PAD SLING (STERILE) BUCKMAN CO., INC.
K072715 09/25/2007 REALHAND HIGH DEXTERITY INSTRUMENTS NOVARE SURGICAL SYSTEMS, INC.
K013300 10/03/2001 MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM TECHNOLOGY DELIVERY SYSTEMS, INC.
K844033 10/15/1984 MOBILIMB HAND UNIT DANNINGER MEDICAL TECHNOLOGY, INC.
K993503 10/15/1999 HAIDER-UCR SPINAL SYSTEM INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC.
K964219 10/22/1996 ZIP CONDOM CATHETER GOULTER MEDICAL, INC.
K964252 10/24/1996 ORTHOCHUCK BUCKMAN CO., INC.
K983798 10/28/1998 SEDATELEC ASP ACUPUNCTURE NEEDLES SEDATELEC
K983800 10/28/1998 DN ACUPUNTURE NEEDLES SEDATELEC
K964354 10/31/1996 ARTOCOOL-S WATER CIRCULATING COLD PACK ORMED GMBH
K023682 11/01/2002 ENCLOSE ANASTOMOSIS ASSIST DEVICE NOVARE SURGICAL SYSTEMS, INC.
K955050 11/03/1995 JETSTREAM CAVITY PREPARATION SYSTEM DOVE SYSTEMS, INC.
K874571 11/05/1987 PATIENTWATCH (TM) ADVANCED MEDICAL TECHNOLOGY, INC.
K003440 11/06/2000 SOFTLASE - SURGICAL DIODE LASER SYSTEM ZAP LASERS, INC.
K003463 11/07/2000 SOCON SPINAL SYSTEM AESCULAP, INC.
K874593 11/09/1987 ACE SELFTAPPING CANCELLOUS BONE SCREW ACE MEDICAL CO.
K874669 11/13/1987 ACE BONE SCREW NUT BUCKMAN CO., INC.
K874670 11/13/1987 ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW BUCKMAN CO., INC.
K874672 11/13/1987 ACE CORTICAL LAG SCREW BUCKMAN CO., INC.
K884740 11/14/1988 EURO-MED LIGHT TOUCH BIOPSY PUNCH BUCKMAN CO., INC.
K993926 11/18/1999 OMNIAXIAL CONNECTOR ORTHOTEC, L.L.C.
K935593 11/19/1993 ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K993942 11/19/1999 LITESABER 2000 LASER DENTAL INNOVATIONS
K884868 11/21/1988 OBSTETRICAL SAFETY SYSTEM BUCKMAN CO., INC.
K896634 11/22/1989 CARAGLAS "XTRA" SYNTHETIC CASTING TAPE BUCKMAN CO., INC.
K935646 11/23/1993 FX-CABLELOK(TM) "STOP"(TROCHANTER HOOK) SYSTEM BIODYNAMIC TECHNOLOGIES, INC.
K964799 11/29/1996 ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY ORMED GMBH
K964802 11/29/1996 CYBERJET LOCAL ANESTHESIA SYSTEM INTRA VANTAGE, INC.
K994041 11/29/1999 TORNIER BIPOLAR RADIAL HEAD PROSTHESIS TORNIER, INC.
K994054 11/30/1999 ISSA PHAROS VAMS TEC, D.O.O.
K874880 12/01/1987 COLORED CASTING TAPE CARAGLAS(TM GREEN SYNTHETIC MFG., INC.
K874882 12/01/1987 ACROMED CROSS ROD CONNECTOR ACROMED CORP.
K083567 12/03/2008 GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW CO-LIGNE AG
K875012 12/04/1987 ACE/FISCHER PERCUTANEOUS HALF PINS BUCKMAN CO., INC.
K875013 12/04/1987 ACE PERCUTANEOUS 3MM HALF-PINS BUCKMAN CO., INC.
K875021 12/04/1987 ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM BUCKMAN CO., INC.
K875022 12/04/1987 ACE/FISHER PERCUTANEOUS TRANSFIXING PINS BUCKMAN CO., INC.
K003728 12/04/2000 MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM TORNIER
K003740 12/04/2000 MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION AESCULAP, INC.
K003759 12/06/2000 AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR AESCULAP, INC.
K984374 12/07/1998 SURGISORB SAMYANG CORP.
K994146 12/08/1999 EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP PLUS ORTHOPEDICS
K875053 12/09/1987 ACROMED CANCELLOUS BONE SCREW BUCKMAN CO., INC.
K875054 12/09/1987 ACROMED ADS BONE NAIL DRIVER BUCKMAN CO., INC.
K014079 12/11/2001 DR. HAYS BITE GUARD INVENTIVE RESOURCES, INC.
K935950 12/13/1993 FX-CABLELOK CABLE/PLATE SYSTEM BUCKMAN CO., INC.
K864892 12/15/1986 ELLISON ARTHROSCOPY CHEATER BUCKMAN CO., INC.
K974641 12/15/1997 FUTURELASE 3000/3002 ERBIUM LASER SYSTEM BUCKMAN CO., INC.
K043484 12/17/2004 LANX SPINAL FIXATION SYSTEM LANX, LLC
K994288 12/20/1999 5.0MM SPINAL SCREWS ORTHOTEC, L.L.C.
K994329 12/22/1999 IIVS INTEGRATED IMAGE VIEWING STATION TERARECON, INC.
K994392 12/28/1999 AEQUALIS SHOULDER FRACTURE SYSTEM TORNIER
K994393 12/28/1999 AEQUALIS UNIVERSAL SHOULDER GLENOID TORNIER


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