FDA 510(k) Applications for Medical Device Product Code "DZL"
(Screw, Fixation, Intraosseous)

FDA 510(k) Number Applicant Device Name Decision Date
K951510 ACE SURGICAL SUPPLY CO., INC. ACE BONE SCREW TACKING KIT 08/25/1995
K063769 ALPHA-BIO TEC LTD ALPHA BIO BONE FIXATION SCREW SYSTEM 03/30/2007
K973056 BICON, INC. BONE GRAFT SCREW SYSTEM 11/12/1997
K993493 BIOHORIZONS IMPLANT SYSTEMS, INC. THE AUTOTAC SYSTEM 01/07/2000
K011675 BIOHORIZONS IMPLANT SYSTEMS, INC. THE AUTOTAC SYSTEM 06/22/2001
K022790 BIOHORIZONS IMPLANT SYSTEMS, INC. THE AUTOTAC SYSTEM TITANIUM TACK 08/28/2002
K140908 BIOMET SPORTS MEDICINE JUGGERKNOT MINI SOFT ANCHOR 10/02/2014
K981666 BIOMET, INC. 2.5 MM LACTOSORB SCREWS 11/03/1998
K002423 BIOMET, INC. LACTOSORB PUSH SCREW 10/20/2000
K981459 BIOMET, INC. MEMBRANE TACK 07/14/1998
K012908 BIOPLATE, INC. BIOPLATE RESORBABLE BONE SCREW 11/28/2001
K974392 BIOVISION GMBH LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM 01/30/1998
K955140 BRASSELER USA I, L.P. 2.0 X 6MM SCREW 01/05/1996
K974817 DOCTOR'S RESEARCH GROUP, INC. DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM 03/13/1998
K981881 DOCTOR'S RESEARCH GROUP, INC. DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING 12/02/1998
K151540 ELI-KA TECHNOLOGIES MC BIO Supertack Tack 3mm, 4mm and 5mm 05/26/2016
K132212 HAGER & MEISINGER GMBH DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL 02/14/2014
K130682 HAGER & MEISINGER GMBH MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT 08/13/2013
K770131 HOWMEDICA CORP. LEW PROSTHETIC LOCKING DEVICE 01/28/1977
K761228 HOWMEDICA CORP. LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM 12/15/1976
K972480 IMPLANT INNOVATIONS, INC. 3I BIORESORBABLE FIXATION TACK 12/23/1997
K982951 IMTEC CORP. IMTEC BIOPIN 06/21/1999
K973180 IMTEC CORP. IMTEC BONE TAC 11/18/1997
K952167 INTERPORE INTL. IMZ BONE TACK SYSTEM 11/21/1995
K960945 INTERPORE INTL. IMZ MEMBRANE TACK SYSTEM 05/24/1996
K171831 Intra-Lock International, Inc. Intra-Lock Bone Fixation System 10/26/2017
K101902 JEIL MEDICAL CORPORATION J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 02/08/2011
K103084 JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S NEODENT GRAFT SCREW 02/14/2011
K982927 KINAMED, INC. QUICK TAP SELF DRILLING SCREW 09/08/1998
K083432 KLS MARTIN L.P. DRILL FREE MMF SCREW 03/31/2009
K042573 KLS-MARTIN L.P. KLS MARTIN DRILL-FREE MMF SCREW 10/18/2004
K980760 KLS-MARTIN L.P. KLS-MARTIN MMF SCREW 12/21/1999
K092855 MILTEX, INC. MILTEX MEMBRANE TACK KIT 12/29/2009
K992623 MITEK PRODUCTS MITEK MINI ANCHOR 11/02/1999
K993575 MITEK PRODUCTS RESOLVE QUICKANCHOR 12/29/1999
K993327 MITEK PRODUCTS TALON ANCHOR SNAP-PAK 12/16/1999
K160991 NEOBIOTECH CO., LTD. Neo GBR System 01/10/2017
K093719 OSTEOGENICS BIOMEDICAL, INC. PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# 03/01/2010
K151195 OSTEOMED OsteoMed IMF Screw 09/21/2015
K012486 OSTEOMED CORP. OSTEOMED BIORESORBABLE FIXATION SYSTEM 01/16/2002
K961418 OSTEOMED CORP. OSTEOMED MSS 10/25/1996
K962774 OSTEOMED CORP. OSTEOMED QUICKFIX 10/10/1997
K911936 OSTEOMED CORP. OSTEOMED SBF SYSTEM (SBF) 08/21/1991
K161857 Salvin Dental Specialties Salvin Tenting Screw System 04/28/2017
K100182 SALVIN DENTAL SPECIALTIES, INC. SALVIN DENTAL SPECIALTIES FIXATION SCREW 05/10/2010
K073342 SALVIN DENTAL SPECIALTIES, INC. SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW 03/26/2008
K080430 STORZ AM MARK GMBH STOMA BONE BLOCK SCREW 11/21/2008
K051871 STORZ AM MARK GMBH STOMA BONE SCREW 10/27/2005
K050515 STRAUMANN USA, INC. BONE BLOCK FIXATION SET 04/05/2005
K050535 STRYKER INSTRUMENTS STRYKER MMF SCREW 03/17/2005
K093464 SYNTHES (USA) RAPIDSORB PLUS SCREW SYSTEM 01/25/2010
K964261 SYNTHES (USA) SMF STAINLESS STEEL BONE SCREWS 04/11/1997
K963546 SYNTHES (USA) SMF TITANIUM (TI) ALLOY BONE SCREWS 06/24/1997
K041887 SYNTHES (USA) SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS 08/19/2004
K021850 SYNTHES (USA) SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS 06/10/2002
K981362 SYNTHES (USA) SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR 06/29/1998
K010527 SYNTHES (USA) SYNTHES (USA) IMF SCREWS 04/25/2001
K050606 SYNTHES (USA) SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) 04/06/2005
K983485 SYNTHES (USA) SYNTHES 1.3 MM SELF-DRILLING SCREW 12/21/1998
K002935 SYNTHES (USA) SYNTHES 1.5MM TI BROW LIFT SCREW 11/16/2000
K980199 SYNTHES (USA) SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS 04/17/1998
K031807 SYNTHES (USA) SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS 07/02/2003
K010690 SYNTHES (USA) SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR 05/18/2001
K911165 TEKNO-MEDICAL SCREW, BONE, MAXILLOFACIAL 08/20/1991
K955369 THE STRAUMANN CO. MEMFIX 01/23/1996
K910427 W.L. GORE & ASSOCIATES,INC MEMFIX SCREWS 09/30/1991
K021522 WALTER LORENZ SURGICAL, INC. LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW 05/21/2002
K983728 WALTER LORENZ SURGICAL, INC. LORENZ IMF SCREW 05/13/1999


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