PHX

Product Code: PHX


Products Classified as PHX

4683Shoulder Prosthesis, Reverse ConfigurationShoulder Joint Metal/polymer Semi-constrained Cemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4683Shoulder Prosthesis, Reverse ConfigurationShoulder Joint Metal/polymer Semi-constrained Cemented Prosthesis.

FDA Consensus Standards

Shoulder Prosthesis, Reverse Configuration [34059]21 CFR §888.3660 🔎

Pre-market Notifications for PHX

K223211INHANCETM Shoulder System – Humeral Stems And StemlessDepuy Ireland UC
K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC
K220914Tornier Perform Humeral System – FractureTornier, Inc.
K213459Glenoid Reconstruction SystemMedacta International S.A.
K213349Catalyst R1 Reverse Shoulder SystemCatalyst OrthoScience, Inc
K213117FX V135 Shoulder ProsthesisFX Shoulder USA, Inc.
K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG
K212800PRIMA Humeral System And SMR Glenosphere Ø42LimaCorporate S.p.A.
K212737INHANCEâ„¢ Reverse Shoulder SystemDepuy Ireland UC
K212710GLOBAL UNITEâ„¢ Platform Shoulder SystemDePuy Ireland UC
K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex Inc.
K211991Catalyst R1 Reverse Shoulder SystemCatalyst OrthoScience, Inc.
K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp.
K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. DBA Tecomet, Inc.
K211359Tornier Performâ„¢ Patient-Matched Primary Reversed Glenoid And BLUEPRINTâ„¢ Patient Specific InstrumentationTornier, Inc.

Global Unique Device Identification Database

00811813020303Shoulder Prosthesis, Reverse Configuration
00811813020297Shoulder Prosthesis, Reverse Configuration
00811813020280Shoulder Prosthesis, Reverse Configuration
00811813020235Shoulder Prosthesis, Reverse Configuration
00811813020204Shoulder Prosthesis, Reverse Configuration
00811813020167Shoulder Prosthesis, Reverse Configuration
00811813020150Shoulder Prosthesis, Reverse Configuration
00811813020143Shoulder Prosthesis, Reverse Configuration
00811813020136Shoulder Prosthesis, Reverse Configuration
00811813020129Shoulder Prosthesis, Reverse Configuration
00811813020112Shoulder Prosthesis, Reverse Configuration
00811813020105Shoulder Prosthesis, Reverse Configuration
00811813020099Shoulder Prosthesis, Reverse Configuration
00811813020082Shoulder Prosthesis, Reverse Configuration
00811813020075Shoulder Prosthesis, Reverse Configuration

Maude Adverse Events

RSPGLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRALENCORE MEDICAL L.P.2020-03-31
RSPRSP STANDARD HUMERAL SOCKET INSERT, 32MM, HXE-PLUSENCORE MEDICAL L.P.2020-03-31
RSPRSP HUMERAL SOCKET INSERT, 36MM +4MM, STANDARD HXE-PLUSENCORE MEDICAL L.P.2020-03-31
AEQUALIS PERFORM REVERSE SHOULDER SYSTEMTORNIER INC2020-03-30
RSPGLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRALENCORE MEDICAL L.P.2020-03-27
RSPGLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRALENCORE MEDICAL L.P.2020-03-27
RSPRSP BASEPLATE, 30MM, W/P2 COATINGENCORE MEDICAL L.P.2020-03-27
RSPGLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRALENCORE MEDICAL L.P.2020-03-27
RSPGLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRALENCORE MEDICAL L.P.2020-03-27
ALTIVATE REVERSE SHOULDERENCORE MEDICAL L.P.2020-03-26
RSPRSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 36MM, HXE-PLUSENCORE MEDICAL L.P.2020-03-26
RSPRSP STANDARD HUMERAL SOCKET INSERT, 32MM, HXE-PLUSENCORE MEDICAL L.P.2020-03-25
RSPRSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXE-PLUSENCORE MEDICAL L.P2020-03-24
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER ?36/+3MMMEDACTA INTERNATIONAL SA2020-03-24
REVERSE SHOULDER SYSTEM GLENOSPHERE 32X?22MEDACTA INTERNATIONAL SA2020-03-24
CR PROLONG 40MM BRNG STDZIMMER BIOMET, INC.2020-03-23
MINI TRAY STD COCR +0 OFFSETZIMMER BIOMET, INC.2020-03-23
HUMELOCK REVERSEDFX SOLUTIONS2020-03-23
RSPRSP HUM SOCKET INSERT, 32MM, +4MM, STANDARDENCORE MEDICAL L.P.2020-03-20
RSPRSP HUM SOCKET INSERT, 36MM +4MM, STANDARDENCORE MEDICAL L.P.2020-03-20
RSPRSP HUMERAL SOCKET INSERTENCORE MEDICAL L.P2020-03-20
HUMELOCK IIFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMERISFX SOLUTIONS2020-03-20
HUMELOCK IIFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMERISFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
HUMELOCK REVERSEDFX SOLUTIONS2020-03-20
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