FDA 510(k) Applications Submitted by Stryker

FDA 510(k) Number Submission Date Device Name Applicant
K173841 12/18/2017 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm Stryker
K123486 11/13/2012 TRIATHLON TRITANIUM TIBIAL BASEPLATE Stryker
K171391 05/11/2017 Stryker 90-S Max SERFAS Energy Probe Stryker
K160955 04/05/2016 Tritanium« PL Cage STRYKER
K162262 08/11/2016 Tritanium« PL Cage STRYKER
K170773 03/14/2017 Stryker Universal Mesh Stryker
K171364 05/09/2017 MP LeFort I Plates Stryker
K173074 09/29/2017 ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor Stryker
K120352 02/06/2012 STRYKER QUIKFLAP STERILE PROCEDURE PACK Stryker
K121235 04/24/2012 LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM Stryker
K133285 10/25/2013 STRYKER TEMPORARY CONDYLAR PROSTHESIS Stryker
K123786 12/10/2012 STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM Stryker
K173866 12/20/2017 Stryker AIM Light Source and SafeLight cable Stryker
K123452 11/08/2012 TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM Stryker
K170725 03/09/2017 Stryker Universal Mesh Stryker
K171152 04/20/2017 Stryker Universal Neuro III System AXS Screw Stryker
K151387 05/26/2015 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade STRYKER
K161821 07/01/2016 Stryker Universal Mesh Stryker
K152076 07/27/2015 PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority Stryker
K172572 08/28/2017 Stryker Upper-Face AXS screws and Mid-Face AXS screws Stryker
K153248 11/09/2015 PEEK Customized Cranial Implant STRYKER
K153508 12/07/2015 Stryker CMF MEDPOR Customized Implant Stryker
K142568 09/12/2014 Stryker MEDPOR TITAN 3D Orbital Floor Implant Stryker
K143173 11/04/2014 Stryker CMF MEDPOR Customized Implant Stryker
K133461 11/12/2013 STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM Stryker
K181083 04/24/2018 Stryker All-PEEK Knotless Anchor System Stryker
K171465 05/18/2017 Stryker Self-Punching ICONIX Stryker
K172921 09/25/2017 Stryker Self-Punching ICONIX Stryker
K120509 02/21/2012 STRYKER ALL SUTURE ANCHORS Stryker
K121153 04/16/2012 PEEK CUSTOMIZED CRAIAL IMPLANT KIT Stryker
K131775 06/17/2013 UNIVERSAL NEURO 3 SYSTEM Stryker
K113109 10/20/2011 STRYKER RESORBABLE FIXATION SYSTEM Stryker
K133398 11/06/2013 STRYKER PEDIATRIC MANDIBLE DISTRACTOR Stryker
K120816 03/19/2012 INZONE DETACHMENT SYSTEM Stryker
K143661 12/23/2014 DirectInject STRYKER
K173476 11/09/2017 Tritanium« TL Curved Posterior Lumbar Cage Stryker
K151667 06/19/2015 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm Stryker
K122313 08/01/2012 STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM Stryker
K132519 08/12/2013 STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT Stryker
K112557 09/02/2011 STRYKER UNIVERSAL NEURO 3 SYSTEM Stryker
K152304 08/14/2015 Tritanium PL Cage Stryker
K170098 01/11/2017 ICONIX TT All Suture Anchor Stryker
K150584 03/09/2015 Stryker Suture Tape Stryker
K151201 05/05/2015 Stryker ICONIX with Needles Stryker
K162310 08/17/2016 XBraid TT Suture Tape Stryker
K061108 04/20/2006 STRYKER AUTO IRRIGATION SYSTEM Stryker
K112059 07/19/2011 T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP Stryker
K060763 03/21/2006 STRYKER INJECTABLE CEMENT Stryker


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