ClearanceBrief
Panels › Orthopedic › Product code PHX · Class 2

Shoulder Prosthesis, Reverse Configuration

Regulation 888.3660

18510(k)s in 12 months (207 all time)
12recalls in 12 months (69 all time)
69recalls that name a 510(k)
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Top companies in PHX

Company510(k)sRecalls
Exactech, Inc.2123
Encore Medical L.P.1816
Tornier183
Biomet Manufacturing Corp150
Zimmer GmbH105
DePuy Orthopaedics, Inc.68
Medacta International S.A.130
Arthrex, Inc.110
Lima Corporate S.P.A.110
Biomet Corporation46
Decided510(k)Device and applicantCode
Dec 6, 2012K121067EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE
Exactech, Inc.
PHX
Dec 3, 2012K122692ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS
Zimmer, Inc.
PHX
Sep 6, 2012K122442DEPUY CTA REVERSE SHOULDER SYSTEM
Depuy France
PHX
Jul 26, 2012K121183COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
Biomet Corporation
PHX
Jul 12, 2012K112193ARROW REVERSE SHOULDER SYSTEM
Fournitures Hospitalieres Industrie, FR
PHX
Jul 9, 2012K120374SEVIIN REVERSE SHOULDER
Ingen Orthopedics, LLC
PHX
Jul 5, 2012K120739AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
Tornier, Inc.
PHX
Jun 11, 2012K120174DEPUT DELTA XTEND REVERSE SHOULDER
Depuy France
PHX
Mar 13, 2012K112144AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS
Tornier, FR
PHX
Feb 24, 2012K113254SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS
Lima Corporate S.P.A.
PHX
Feb 16, 2012K120121COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
Biomet, Inc.
PHX
Jan 11, 2012K113069COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
Biomet Manufacturing Corp
PHX
Dec 20, 2011K113523LIMACORPORATE SMR REVERSE SHOULDER SYSTEM
Lima Corporate S.P.A.
PHX
Dec 16, 2011K113121COMPREHENSIVE REVERSE SHOULDER
Biomet Manufacturing, Inc.
PHX
Nov 15, 2011K112069RSP GLENOID BASEPLATE POROUS COATED
Encore Medical L.P.
PHX
Oct 28, 2011K103251DUOCENTRIC REVERSED
Aston Medical
PHX
Oct 11, 2011K112615AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
Tornier, Inc.
PHX
Oct 3, 2011K111735REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER
Encore Medical L.P.
PHX
Sep 16, 2011K111629TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001
Encore Medical L.P.
PHX
Aug 18, 2011K110598SMR REVERSE SHOULDER SYSTEM
Lima Corporate S.P.A.
PHX
Jul 20, 2011K111061REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
Encore Medical L.P.
PHX
Jun 14, 2011K110599AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
Tornier, Inc.
PHX
Apr 1, 2011K110708EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
Exactech, Inc.
PHX
Jan 31, 2011K103208REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
Encore Medical L.P.
PHX
Dec 15, 2010K101996DEPUY GLOBAL UNITE SHOULDER SYSTEM
Depuy(Ireland), IE
PHX
Nov 4, 2010K102951EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)
Exactech, Inc.
PHX
Oct 19, 2010K093803BIO-MODULAR REVERSE SHOLDER
Biomet Manufacturing Corp
PHX
Aug 2, 2010K101909EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
Exactech, Inc.
PHX
Aug 2, 2010K100741REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012
Encore Medical L.P.
PHX
May 27, 2010K093275EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER
Exactech, Inc.
PHX
May 6, 2010K100142AEQUALIS REVERSED SHOULDER PROSTHESIS
Tornier, FR
PHX
Jan 7, 2010K092900EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
Exactech, Inc.
PHX
Oct 27, 2009K092873REVERSE SHOULDER PROSTHESIS
Djo Surgical
PHX
Oct 10, 2008K082702EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
Exactech, Inc.
PHX
Sep 5, 2008K081016SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
Smith & Nephew, Inc.
PHX
Jul 17, 2008K081059AEQUALIS REVERSED SHOULDER PROSTHESIS
Tornier, FR
PHX
Jul 9, 2008K080642COMPREHENSIVE REVERSE SHOULDER
Biomet, Inc.
PHX
Feb 29, 2008K073688EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW
Exactech, Inc.
PHX
Jan 29, 2008K073676DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP
DePuy Orthopaedics, Inc.
PHX
Dec 12, 2007K072804COMPREHENSIVE RS SHOULDER SYSTEM
Biomet Manufacturing Corp
PHX
Oct 18, 2007K071948AEQUALIS REVERSED ADAPTER
Tornier, FR
PHX
Sep 11, 2007K071379DELTA XTEND REVERSE SHOULDER MODULAR STEM
DePuy Orthopaedics, Inc.
PHX
Feb 23, 2007K063569EQUINOXE REVERSE SHOULDER SYSTEM
Exactech, Inc.
PHX
Feb 2, 2007K062250DELTA XTEND REVERSE SHOULDER SYSTEM
DePuy Orthopaedics, Inc.
PHX
Aug 18, 2006K062116DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS
DePuy Orthopaedics, Inc.
PHX
Jul 20, 2006K061439AEQUALIS REVERSED PROSTHESIS
Tornier, FR
PHX
May 19, 2006K060704ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM
Zimmer, Inc.
PHX
Jan 25, 2006K053274ANATOMICAL SHOULDER INVERSE/REVERSE
Zimmer GmbH
PHX
Dec 19, 2005K052906ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
Zimmer, Inc.
PHX
Aug 31, 2005K052086ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER
Encore Medical, Inc.
PHX

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