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205 FDA 510(k) clearances · Product code

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RecordFirmDate
Exactech Equinoxe Small Reverse Shoulder System (K180632)Exactech, Inc.2018-07-25
Integra TITAN Reverse Shoulder System (K173717)Integra LifeSciences Corporation2018-06-21
Arthrex Univers Revers Modular Glenoid System (K173900)Arthrex, Inc.2018-04-20
Medacta Shoulder System Short Humeral Diaphysis (K180089)Medacta International S.A.2018-04-05
Arthrex UNIVERS REVERS COATED BASEPLATE (K172371)Arthrex, Inc.2018-03-22
Comprehensive Segmental Revision System (SRS) (K173411)Biomet Manufacturing Corp2018-02-08
ARROW Reverse Porous Glenoid (K171789)Fournitures Hospitalieres Industrie2018-01-23
GLOBAL UNITE Platform Shoulder System (K170748)Depuy Ireland UC2018-01-11
Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate (K172502)Biomet Manufacturing Corp2018-01-03
AltiVate Anatomic to Reverse Conversion Module (K173073)Encore Medical L.P.2017-12-26
Arthrex Univers Revers Apex Humeral Stems (K170414)Arthrex, Inc.2017-12-14
Medacta Shoulder System: Threaded Glenoid Baseplate (K171058)Medacta International S.A.2017-12-13
Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid (K172767)Zimmer, Inc.2017-11-30
Medacta Shoulder System (K170452)Medacta International S.A.2017-10-05
ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System (K170711)Zimmer GmbH2017-06-01
Humeris Shoulder (K163669)Fx Solutions2017-05-17
Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw (K162325)Exactech, Inc.2017-03-06
SMR TT Metal Back Glenoid, Bone Graft instruments (K161120)Lima Corporate S.P.A.2017-02-21
Exactech® Equinoxe® Preserve Stem (K162726)Exactech, Inc.2017-02-01
Humelock Reversed Shoulder (K162455)Fx Solutions2017-01-17
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid (K161742)Tornier, Inc.2016-11-15
Integra TITAN Reverse Shoulder System (K161189)Integra LifeSciences Corporation2016-08-25
COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) (K152754)Biomet Manufacturing Corp2016-05-16
Aequalis Fx2 (K152966)Tornier S.A.S.2016-01-14
Humelock II Reversible Shoulder System (K150488)Fx Solutions2015-11-13
ARROW Humeral stems size 6 and 16 (K150568)Fournitures Hospitalieres Industrie2015-10-29
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere (K150458)Exactech, Inc.2015-05-14
ARROW Reverse Shoulder long keel and short keel glenoid base (K142778)Fournitures Hospitalieres Industrie2015-03-20
Univers Rivers Shoulder Prosthesis System (K142863)Arthrex, Inc.2014-11-25
AEQUALIS FX2 (K141345)Tornier S.A.S.2014-11-18
ENCORE HUMERAL SHOULDER STEM (K141990)Encore Medical L.P.2014-11-07
SMR 40MM GLENOSPHERE (K142139)Lima Corporate S.P.A.2014-11-07
AEQUALIS REVERSED SHOULDER PROSTHESIS (K140478)Tornier S.A.S.2014-08-06
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM (K140082)Tornier S.A.S.2014-07-18
POROUS COATED COMPREHENSIVE FRACTURE STEMS (K140652)Biomet Manufacturing Corp2014-07-03
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM (K141029)Tornier, Inc.2014-06-18
RSP HUMERAL SOCKET INSERT (K141006)Djo Global2014-06-05
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM (K133378)Zimmer, Inc.2014-05-12
RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 (K140904)Encore Medical L.P.2014-05-06
RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW (K130550)Encore Medical L.P.2014-03-24
REUNION RSA SHOULDER SYSTEM (K130895)Howmedica Osteonics Corp.2013-12-27
AEQUALIS REVERSED SHOULDER PROSTHESIS (K132285)Tornier S.A.S.2013-12-05
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS (K131231)Tornier S.A.S.2013-10-16
COMPREHENSIVE CONVERTIBLE GLENOID (K130390)Biomet Manufacturing, Inc.2013-10-09
COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE (K131353)Biomet Manufacturing Corp2013-10-08
COMPREHENSIVE REVERSE SHOULDER SCREWS (K132239)Biomet Manufacturing Corp2013-09-06
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT (K131575)Exactech, Inc.2013-07-03
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM (K130661)Zimmer, Inc.2013-05-09
EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE (K121067)Exactech, Inc.2012-12-06
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS (K122692)Zimmer, Inc.2012-12-03
DEPUY CTA REVERSE SHOULDER SYSTEM (K122442)Depuy France2012-09-06
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS (K121183)Biomet Corporation2012-07-26
ARROW REVERSE SHOULDER SYSTEM (K112193)Fournitures Hospitalieres Industrie2012-07-12
SEVIIN REVERSE SHOULDER (K120374)Ingen Orthopedics, LLC2012-07-09
AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM (K120739)Tornier, Inc.2012-07-05
DEPUT DELTA XTEND REVERSE SHOULDER (K120174)Depuy France2012-06-11
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS (K112144)Tornier2012-03-13
SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS (K113254)Lima Corporate S.P.A.2012-02-24
COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE (K120121)Biomet, Inc.2012-02-16
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY (K113069)Biomet Manufacturing Corp2012-01-11
LIMACORPORATE SMR REVERSE SHOULDER SYSTEM (K113523)Lima Corporate S.P.A.2011-12-20
COMPREHENSIVE REVERSE SHOULDER (K113121)Biomet Manufacturing, Inc.2011-12-16
RSP GLENOID BASEPLATE POROUS COATED (K112069)Encore Medical L.P.2011-11-15
DUOCENTRIC REVERSED (K103251)Aston Medical2011-10-28
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM (K112615)Tornier, Inc.2011-10-11
REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER (K111735)Encore Medical L.P.2011-10-03
TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 (K111629)Encore Medical L.P.2011-09-16
SMR REVERSE SHOULDER SYSTEM (K110598)Lima Corporate S.P.A.2011-08-18
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) (K111061)Encore Medical L.P.2011-07-20
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM (K110599)Tornier, Inc.2011-06-14
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... (K110708)Exactech, Inc.2011-04-01
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM (K103208)Encore Medical L.P.2011-01-31
DEPUY GLOBAL UNITE SHOULDER SYSTEM (K101996)Depuy(Ireland)2010-12-15
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) (K102951)Exactech, Inc.2010-11-04
BIO-MODULAR REVERSE SHOLDER (K093803)Biomet Manufacturing Corp2010-10-19
EXACTECH EQUINOXE, PLATFORM FRACTURE STEM (K101909)Exactech, Inc.2010-08-02
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 (K100741)Encore Medical L.P.2010-08-02
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER (K093275)Exactech, Inc.2010-05-27
AEQUALIS REVERSED SHOULDER PROSTHESIS (K100142)Tornier2010-05-06
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM (K092900)Exactech, Inc.2010-01-07
REVERSE SHOULDER PROSTHESIS (K092873)Djo Surgical2009-10-27
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY (K082702)Exactech, Inc.2008-10-10
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM (K081016)Smith & Nephew, Inc.2008-09-05
AEQUALIS REVERSED SHOULDER PROSTHESIS (K081059)Tornier2008-07-17
COMPREHENSIVE REVERSE SHOULDER (K080642)Biomet, Inc.2008-07-09
EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW (K073688)Exactech, Inc.2008-02-29
DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP (K073676)DePuy Orthopaedics, Inc.2008-01-29
COMPREHENSIVE RS SHOULDER SYSTEM (K072804)Biomet Manufacturing Corp2007-12-12
AEQUALIS REVERSED ADAPTER (K071948)Tornier2007-10-18
DELTA XTEND REVERSE SHOULDER MODULAR STEM (K071379)DePuy Orthopaedics, Inc.2007-09-11
EQUINOXE REVERSE SHOULDER SYSTEM (K063569)Exactech, Inc.2007-02-23
DELTA XTEND REVERSE SHOULDER SYSTEM (K062250)DePuy Orthopaedics, Inc.2007-02-02
DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS (K062116)DePuy Orthopaedics, Inc.2006-08-18
AEQUALIS REVERSED PROSTHESIS (K061439)Tornier2006-07-20
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM (K060704)Zimmer, Inc.2006-05-19
ANATOMICAL SHOULDER INVERSE/REVERSE (K053274)Zimmer GmbH2006-01-25
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM (K052906)Zimmer, Inc.2005-12-19
ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER (K052086)Encore Medical, Inc.2005-08-31
ENCORE REVERSE SHOULDER PROSTHESIS (K051075)Encore Medical L.P.2005-05-27
DELTA HUMERAL CUPS (K050315)DePuy Orthopaedics, Inc.2005-05-16
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