FDA 510(k) Applications Submitted by Synthes (USA) Products LLC

FDA 510(k) Number Submission Date Device Name Applicant
K140462 02/24/2014 MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) SYNTHES (USA) PRODUCTS LLC
K111437 05/24/2011 SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) SYNTHES (USA) PRODUCTS LLC
K112085 07/21/2011 SYNTHES LCP PEDIATRIC PLATE SYSTEMS SYNTHES (USA) PRODUCTS LLC
K111891 07/05/2011 SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS SYNTHES (USA) PRODUCTS LLC
K141165 05/06/2014 MATRIXWAVE MMF SYSTEM SYNTHES (USA) PRODUCTS LLC
K133616 11/25/2013 MATRIXRIB FIXATION SYSTEM SYNTHES (USA) PRODUCTS LLC
K150673 03/16/2015 SYNFIX Evolution Secured Spacer System SYNTHES (USA) PRODUCTS LLC
K183472 12/14/2018 DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio û MR Conditional Synthes (USA) Products LLC
K122639 08/29/2012 SYNTHES SYNCAGE EVOLUTION SPACER SYNTHES (USA) PRODUCTS LLC
K190963 04/12/2019 DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional Synthes (USA) Products LLC
K192702 09/27/2019 DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional Synthes (USA) Products LLC
K141796 07/03/2014 DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM SYNTHES (USA) PRODUCTS LLC
K131276 05/06/2013 LATERAL SYNFIX SYNTHES (USA) PRODUCTS LLC
K123180 10/10/2012 FALCON SPACER SYNTHES (USA) PRODUCTS LLC
K111230 05/02/2011 SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW SYNTHES (USA) PRODUCTS LLC
K112583 09/06/2011 SYNTHES CORTICAL SCREWS SYNTHES (USA) PRODUCTS LLC
K113364 11/15/2011 2.7MM LCP ULNA OSTEOTOMY SYSTEM SYNTHES (USA) PRODUCTS LLC
K183113 11/09/2018 DePuy Synthes Maxillofacial Portfolio - MR Conditional Synthes (USA) Products LLC
K131186 04/25/2013 SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM SYNTHES (USA) PRODUCTS LLC
K192655 09/25/2019 Depuy Synthes Maxillofacial Portfolio - MR Conditional Synthes (USA) Products LLC
K141241 05/13/2014 MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM SYNTHES (USA) PRODUCTS LLC
K153587 12/16/2015 Taps for Resorbable Screws SYNTHES (USA) PRODUCTS LLC
K130720 03/18/2013 SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM SYNTHES (USA) PRODUCTS LLC
K161590 06/09/2016 MatrixRIB Fixation System SYNTHES (USA) PRODUCTS LLC
K192327 08/27/2019 DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile Synthes (USA) Products LLC
K120689 03/06/2012 SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM SYNTHES (USA) PRODUCTS LLC


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