FDA 510(k) Applications Submitted by CHRISTOPHER KLACZYK

FDA 510(k) Number Submission Date Device Name Applicant
K070300 01/31/2007 EXPEDIUM SFX CROSS CONNECTOR SYSTEM DEPUY SPINE, INC.
K090242 02/02/2009 GAMMA-BSM, BETA-BSM ETEX CORP.
K160262 02/02/2016 n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, Institut Straumann AG
K080313 02/06/2008 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC.
K090310 02/06/2009 EQUIVABONE ETEX CORP.
K170354 02/06/2017 Straumann Variobase Abutments Institut Straumann AG
K170356 02/06/2017 Straumann Variobase Abutments Institut Straumann AG
K070387 02/09/2007 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC.
K170420 02/13/2017 n!ce Glass Ceramic Blocks for Amann Girrbach Institut Straumann AG
K140737 03/24/2014 STRAUMANN CARES SCREW RETAINED BARS/BRIDGE STRAUMANN USA, LLC
K090855 03/30/2009 EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE ETEX CORP.
K100883 03/30/2010 CARRIGEN ETEX CORP.
K150899 04/03/2015 Straumann CARES Titanium Alloy (TAN) Abutment STRAUMANN USA, LLC
K140878 04/07/2014 STRAUMANN BONE LEVEL TAPERED IMPLANT STRAUMANN USA, LLC
K150938 04/07/2015 Straumann« Dental Implant System ? Roxolid« SLA Implants STRAUMANN USA, LLC
K151157 05/01/2015 NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges STRAUMANN USA, LLC
K081252 05/02/2008 EXPEDIUM 4.5MM SPINE SYSTEM DEPUY SPINE, INC.
K151247 05/11/2015 NC Straumann Screw Retained Abutments STRAUMANN USA, LLC
K151324 05/18/2015 Straumann Variobase for CEREC STRAUMANN USA, LLC
K071495 05/31/2007 EXPEDIUM 4.5MM SPINE SYSTEM DEPUY SPINE, A JOHNSON & JOHNSON COMPANY
K091607 06/03/2009 ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE ETEX CORP.
K101557 06/04/2010 GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN ETEX CORP.
K091729 06/11/2009 ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE ETEX CORP.
K151590 06/12/2015 Straumann RN Gold Abutment for Bridge STRAUMANN USA, LLC
K161677 06/17/2016 Straumann Sterile Healing Solution Institut Straumann AG
K081898 07/03/2008 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC.
K071860 07/05/2007 MODIFICATION TO: VIPER SPINE SYSTEM DEPUY SPINE, INC.
K141871 07/11/2014 Straumann Bone Level NC Angled Screw Retained Abutments STRAUMANN USA, LLC
K052158 08/09/2005 WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE WELCH ALLYN, INC.
K162311 08/18/2016 Straumann PrefGel INSTITUT STRAUMANN AG
K132844 09/11/2013 STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES STRAUMANN USA, LLC
K102812 09/28/2010 GAMMA-BSM; BETA-BSM; EQUIVABONE ETEX CORPORATION
K162848 10/11/2016 Straumann CARES Golden Ti/TiN Abutments INSTITUT STRAUMANN AG
K063156 10/17/2006 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC.
K093447 11/05/2009 CARRIGEN ETEX CORP.
K073126 11/06/2007 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC.
K173562 11/17/2017 Straumann Jason Membrane Institut Straumann AG
K133592 11/22/2013 NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM NEODENT USA, INC.
K073364 11/30/2007 EXPEDIUM 4.5MM SPINE SYSTEM DEPUY SPINE, INC.
K063741 12/18/2006 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC.
K073562 12/19/2007 MODIFICATION TO VIPER SPINE SYSTEM DEPUY SPINE, INC.
K063772 12/21/2006 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC.
K153758 12/30/2015 Straumann Bone Level Tapered Implants INSTITUT STRAUMANN AG
K050074 01/12/2005 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 WELCH ALLYN, INC.
K040232 02/02/2004 LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 LSI SOLUTIONS
K031443 05/06/2003 LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS LSI SOLUTIONS
K024301 12/24/2002 LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT LSI SOLUTIONS


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact