Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
FDA product code HSD · 70 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3690
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1979-09-28 – 2024-02-12
HSD
2024-02-12
HSD
2022-05-19
Univers Revers Humeral Cup Implant
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HSD
2020-11-12
AGILON® XO Shoulder Replacement System
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HSD
2020-05-15
Biocore9 Humeral Resurfacing System
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HSD
2018-04-18
OVOMotion Shoulder Arthroplasty System
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HSD
2016-11-21
Arthrex Univers Revers Shoulder Prosthesis System
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HSD
2016-11-01
Anatomical Shoulder Domelock Dome centric
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HSD
2016-04-19
Arthrex Univers Revers CA Heads and Adapters
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HSD
2013-11-26
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
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HSD
2013-11-09
HUMELOCK II CEMENTLESS SHOULDER SYSTEM
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HSD
2013-10-30
ARTHREX UNIVERS II CA HEADS
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HSD
2013-08-26
SEVIIN SURFACE REPLACEMENT SHOULDER
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HSD
2012-09-07
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
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HSD
2012-06-01
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
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HSD
2011-12-12
SPACER-S
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HSD
2011-11-09
HUMELOCK CEMENTED SHOULDER PROSTHESIS
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HSD
2008-12-18
DEPUY GLOBAL AP CTA HUMERAL HEAD
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HSD
2008-08-08
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
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HSD
2008-02-19
DVO EXTENDED ARTICULATION HUMERAL HEADS
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HSD
2007-11-28
SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
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HSD
2007-06-22
ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA
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HSD
2007-05-04
REUNION HA FRACTURE STEM
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HSD
2007-03-02
PROMOS MODULAR SHOULDER SYSTEM
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HSD
2006-12-22
AEQUALIS RESURFACING HEAD
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HSD
2006-12-13
MODULAR REPLACEMENT ELBOW SYSTEM
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HSD
2006-11-09
AEQUALIS SHOULDER SYSTEM
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HSD
2006-10-31
ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
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HSD
2006-08-28
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
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HSD
2006-07-10
SOLAR PUREFIX HA SHOULDER
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HSD
2006-06-12
EXACTECH EQUINOXE SHOULDER STEMS
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HSD
2006-05-24
SPACER-S TEMPORARY SHOULDER SPACER
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HSD
2005-09-29
COPELAND EAS HUMERAL RESURFACING HEADS
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HSD
2005-01-07
SOLAR 2 ANATOMIC SHOULDER
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HSD
2004-03-26
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
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HSD
2004-01-08
PROMOS SHOULDER
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HSD
2003-12-03
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
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HSD
2003-09-24
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
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HSD
2003-08-08
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
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HSD
2003-04-10
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
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HSD
2002-03-11
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
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HSD
2001-09-14
COPELAND MB/HA RESURFACING HUMERAL HEADS
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HSD
2001-09-14
COPELAND MB RESURFACING HUMERAL HEADS
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HSD
2001-07-13
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
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HSD
2001-04-05
COPELAND RESURFACING HUMERAL HEADS
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HSD
2000-12-13
COPELAND RESURFACING HEADS
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HSD
2000-11-24
ISS OFFSET HEADS
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HSD
2000-07-27
SOLAR SHOULDER OFFSET HUMERAL HEAD
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HSD
2000-02-04
ACUMED MODULAR SHOULDER SYSTEM
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HSD
1999-10-15
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
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HSD
1999-02-05
HOWMEDICA HUMERAL INTERCALARY SYSTEM
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HSD
1998-10-05
OTI MODULAR SHOULDER SYSTEM
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HSD
1997-04-02
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
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HSD
1996-08-29
SELECT SHOULDER COCR HUMERAL STEM COMPONENT
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HSD
1996-07-12
HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
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HSD
1995-05-30
INFINITY SHOULDER SYSTEM
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HSD
1995-05-22
HEMI-SHOULDER PROSTHESIS
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HSD
1994-10-14
ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM
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HSD
1991-10-21
LIMA RPS SHOULDER
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HSD
1991-07-26
BONE NAIL, KUNTSCHER
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HSD
1991-07-15
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
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HSD
1991-06-28
TEMPERLITE(TM) SAW BLADE
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HSD
1991-03-12
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
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HSD
1991-03-12
EXACTECH HUMERAL SHOULDER PROSTHESIS
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HSD
1988-01-06
KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS
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HSD
1987-11-17
SELECT SHOULDER SYSTEM
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HSD
1987-10-01
KIRSCHNER NEER-III PROXIMAL HUMERUS
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HSD
1982-10-06
101 NEER TYPE SHOULDER
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HSD
1980-09-16
MONOSPHERICAL SHOULDER PROSTHESIS
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HSD
1980-03-18
NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS
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HSD
1979-09-28
REXTON HS(HEARING SYSTEM)
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