FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K060692 |
BIOMET MANUFACTURING CORP. |
COMPREHENSIVE PRIMARY SHOULDER STEMS |
05/30/2006 |
K193038 |
Biomet Manufacturing Corp. |
Comprehensive Shoulder System |
10/28/2020 |
K140390 |
BIOMET MANUFACTURING CORP. |
TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS |
09/10/2014 |
K060716 |
BIOMET MANUFACTURING CORP. |
VERSA-DIAL HUMERAL HEAD PROSTHESIS |
06/12/2006 |
K123297 |
BIOMET MANUFACTUTING CORP. |
COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM |
11/20/2012 |
K112905 |
BIOMET ORTHOPEDICS LLC. |
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM |
05/24/2012 |
K183553 |
Biomet, Inc |
Compress and Mini Compress Anti-Rotation Spindles |
01/22/2019 |
K032895 |
BIOMET, INC. |
BI-ANGULAR SHOULDER SYSTEM |
11/20/2003 |
K043100 |
BIOMET, INC. |
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS |
02/17/2005 |
K010635 |
BIOMET, INC. |
INTERLOK / HA COPELAND RESURFACING HEADS |
08/20/2001 |
K130126 |
BIOMET, INC. |
SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM |
08/06/2013 |
K231516 |
Depuy Ireland UC |
INHANCEÖ Shoulder System, Sterile Single Use Instrumentation |
07/21/2023 |
K212933 |
Depuy Ireland UC |
INHANCETM Hybrid Anatomic Glenoid Implant |
06/08/2022 |
K011047 |
DEPUY ORTHOPAEDICS, INC. |
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT |
06/28/2001 |
K063652 |
DEPUY ORTHOPAEDICS, INC. |
GLOBAL AP POROUS COATED HUMERAL STEM |
02/01/2007 |
K011099 |
DEPUY ORTHOPAEDICS, INC. |
GLOBAL FX POROUS-COATED HUMERAL STEM |
07/06/2001 |
K081448 |
ENCORE MEDICAL, L.P. |
ENCORE SHOULDER REVISION GLENOID |
09/30/2008 |
K162068 |
Fournitures Hospitalieres Industrie |
ARROW Anatomical Porous glenoid |
04/10/2017 |
K202716 |
Ignite Orthopedics LLC |
Ignite Anatomic Shoulder System |
05/20/2021 |
K191963 |
LimaCorporate S.p.A |
SMR Finned Short Stems |
10/10/2019 |
K222427 |
LimaCorporate S.p.A. |
PRIMA TT Glenoid |
10/06/2022 |
K201905 |
LimaCorporate S.p.A. |
SMR 140░ Reverse Humeral Body |
12/17/2020 |
K163397 |
Limacorporate S.p.A. |
SMR Hybrid Glenoid System |
06/29/2017 |
K220792 |
LimaCorporate S.p.A. |
SMR Reverse Liner |
05/19/2022 |
K223876 |
LimaCorporate S.p.A. |
SMR Shoulder System |
02/03/2023 |
K173824 |
Shoulder Innovations Inc |
Humeral Short Stem System |
10/23/2018 |
K070565 |
SMITH & NEPHEW, INC. |
COFIELD TOTAL SHOULDER SYSTEM |
05/18/2007 |
K083439 |
SYNTHES (USA) |
SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM |
02/05/2009 |
K213856 |
Zimmer Inc. |
Identity Shoulder System |
09/15/2022 |