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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
Sep 28, 2018K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
Arthrex, Inc.
PHX
Sep 24, 2018K181611Comprehensive Reverse Shoulder System
Biomet Manufacturing Corp
PHX
Jul 25, 2018K180632Exactech Equinoxe Small Reverse Shoulder System
Exactech, Inc.
PHX
Jun 21, 2018K173717Integra TITAN Reverse Shoulder System
Integra LifeSciences Corporation
PHX
Apr 20, 2018K173900Arthrex Univers Revers Modular Glenoid System
Arthrex, Inc.
PHX
Apr 5, 2018K180089Medacta Shoulder System Short Humeral Diaphysis
Medacta International S.A., CH
PHX
Mar 22, 2018K172371Arthrex UNIVERS REVERS COATED BASEPLATE
Arthrex, Inc.
PHX
Feb 8, 2018K173411Comprehensive Segmental Revision System (SRS)
Biomet Manufacturing Corp
PHX
Jan 23, 2018K171789ARROW Reverse Porous Glenoid
Fournitures Hospitalieres Industrie, FR
PHX
Jan 11, 2018K170748GLOBAL UNITE Platform Shoulder System
Depuy Ireland UC, IE
PHX
Jan 3, 2018K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
Biomet Manufacturing Corp
PHX
Dec 26, 2017K173073AltiVate Anatomic to Reverse Conversion Module
Encore Medical L.P.
PHX
Dec 14, 2017K170414Arthrex Univers Revers Apex Humeral Stems
Arthrex, Inc.
PHX
Dec 13, 2017K171058Medacta Shoulder System: Threaded Glenoid Baseplate
Medacta International S.A., CH
PHX
Nov 30, 2017K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
Zimmer, Inc.
PHX
Oct 5, 2017K170452Medacta Shoulder System
Medacta International S.A., CH
PHX
Jun 1, 2017K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System
Zimmer GmbH, CH
PHX
May 17, 2017K163669Humeris Shoulder
Fx Solutions, FR
PHX
Mar 6, 2017K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe
Exactech, Inc.
PHX
Feb 21, 2017K161120SMR TT Metal Back Glenoid, Bone Graft instruments
Lima Corporate S.P.A., IT
PHX
Feb 1, 2017K162726Exactech® Equinoxe® Preserve Stem
Exactech, Inc.
PHX
Jan 17, 2017K162455Humelock Reversed Shoulder
Fx Solutions, FR
PHX
Nov 15, 2016K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
Tornier, Inc.
PHX
Aug 25, 2016K161189Integra TITAN Reverse Shoulder System
Integra LifeSciences Corporation
PHX
May 16, 2016K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
Biomet Manufacturing Corp
PHX
Jan 14, 2016K152966Aequalis Fx2
Tornier S.A.S., FR
PHX
Nov 13, 2015K150488Humelock II Reversible Shoulder System
Fx Solutions, FR
PHX
Oct 29, 2015K150568ARROW Humeral stems size 6 and 16
Fournitures Hospitalieres Industrie, FR
PHX
May 14, 2015K150458Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
Exactech, Inc.
PHX
Mar 20, 2015K142778ARROW Reverse Shoulder long keel and short keel glenoid base
Fournitures Hospitalieres Industrie, FR
PHX
Nov 25, 2014K142863Univers Rivers Shoulder Prosthesis System
Arthrex, Inc.
PHX
Nov 18, 2014K141345AEQUALIS FX2
Tornier S.A.S., FR
PHX
Nov 7, 2014K142139SMR 40MM GLENOSPHERE
Lima Corporate S.P.A.
PHX
Nov 7, 2014K141990ENCORE HUMERAL SHOULDER STEM
Encore Medical L.P.
PHX
Aug 6, 2014K140478AEQUALIS REVERSED SHOULDER PROSTHESIS
Tornier S.A.S., FR
PHX
Jul 18, 2014K140082AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
Tornier S.A.S., FR
PHX
Jul 3, 2014K140652POROUS COATED COMPREHENSIVE FRACTURE STEMS
Biomet Manufacturing Corp
PHX
Jun 18, 2014K141029TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
Tornier, Inc.
PHX
Jun 5, 2014K141006RSP HUMERAL SOCKET INSERT
Djo Global
PHX
May 12, 2014K133378ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
Zimmer, Inc.
PHX
May 6, 2014K140904RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6
Encore Medical L.P.
PHX
Mar 24, 2014K130550RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW
Encore Medical L.P.
PHX
Dec 27, 2013K130895REUNION RSA SHOULDER SYSTEM
Howmedica Osteonics Corp.
PHX
Dec 5, 2013K132285AEQUALIS REVERSED SHOULDER PROSTHESIS
Tornier S.A.S., FR
PHX
Oct 16, 2013K131231AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
Tornier S.A.S., FR
PHX
Oct 9, 2013K130390COMPREHENSIVE CONVERTIBLE GLENOID
Biomet Manufacturing, Inc.
PHX
Oct 8, 2013K131353COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE
Biomet Manufacturing Corp
PHX
Sep 6, 2013K132239COMPREHENSIVE REVERSE SHOULDER SCREWS
Biomet Manufacturing Corp
PHX
Jul 3, 2013K131575EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT
Exactech, Inc.
PHX
May 9, 2013K130661ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
Zimmer, Inc.
PHX

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