HSD · Class II · 21 CFR 888.3690

FDA Product Code HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Leading manufacturers include Howmedica Osteonics Corp., Arthrex, Inc. and Exactech, Inc..

71
Total
71
Cleared
120d
Avg days
1979
Since
71 devices
25–48 of 71
Cleared Dec 22, 2006
AEQUALIS RESURFACING HEAD
K062661
Tornier
Orthopedic · 106d
Cleared Dec 13, 2006
MODULAR REPLACEMENT ELBOW SYSTEM
K062845
Howmedica Osteonics Corp.
Orthopedic · 82d
Cleared Nov 09, 2006
AEQUALIS SHOULDER SYSTEM
K063081
Tornier
Orthopedic · 30d
Cleared Oct 31, 2006
ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
K062861
Ascension Orthopedics, Inc.
Orthopedic · 36d
Cleared Aug 28, 2006
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
K061862
Axiom Orthopaedics, Inc.
Orthopedic · 59d
Cleared Jul 10, 2006
SOLAR PUREFIX HA SHOULDER
K061677
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Jun 12, 2006
EXACTECH EQUINOXE SHOULDER STEMS
K061454
Exactech, Inc.
Orthopedic · 18d
Cleared May 24, 2006
SPACER-S TEMPORARY SHOULDER SPACER
K060535
Tecres S.P.A.
Orthopedic · 85d
Cleared Sep 29, 2005
COPELAND EAS HUMERAL RESURFACING HEADS
K051843
Biomet, Inc.
Orthopedic · 84d
Cleared Jan 07, 2005
SOLAR 2 ANATOMIC SHOULDER
K040432
Stryker Orthopaedics
Orthopedic · 323d
Cleared Mar 26, 2004
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
K040128
Howmedica Osteonics Corp.
Orthopedic · 65d
Cleared Jan 08, 2004
PROMOS SHOULDER
K032126
Plus Orthopedics
Orthopedic · 182d
Cleared Dec 03, 2003
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
K033516
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared Sep 24, 2003
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
K031971
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Aug 08, 2003
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
K032264
Howmedica Osteonics Corp.
Orthopedic · 16d
Cleared Apr 10, 2003
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
K023096
Std Mfg., Inc.
Orthopedic · 204d
Cleared Mar 11, 2002
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
K012377
Corin USA
Orthopedic · 228d
Cleared Sep 14, 2001
COPELAND MB RESURFACING HUMERAL HEADS
K010657
Biomet Manufacturing, Inc.
Orthopedic · 192d
Cleared Sep 14, 2001
COPELAND MB/HA RESURFACING HUMERAL HEADS
K010827
Biomet Orthopedics, Inc.
Orthopedic · 178d
Cleared Jul 13, 2001
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
K011942
Tornier
Orthopedic · 22d
Cleared Apr 05, 2001
COPELAND RESURFACING HUMERAL HEADS
K010664
Biomet Manufacturing, Inc.
Orthopedic · 30d
Cleared Dec 13, 2000
COPELAND RESURFACING HEADS
K003044
Biomet, Inc.
Orthopedic · 75d
Cleared Nov 24, 2000
ISS OFFSET HEADS
K003428
Biomet, Inc.
Orthopedic · 21d
Cleared Jul 27, 2000
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419
Howmedica Osteonics Corp.
Orthopedic · 83d