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 Biomet, Inc..

71
Total
71
Cleared
120d
Avg days
1979
Since
71 devices
25–48 of 71
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 Mar 11, 2002
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
K012377
Corin USA
Orthopedic · 228d
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 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
Cleared Feb 04, 2000
ACUMED MODULAR SHOULDER SYSTEM
K992525
Acu Med, Inc.
Orthopedic · 191d
Cleared Feb 05, 1999
HOWMEDICA HUMERAL INTERCALARY SYSTEM
K984202
Howmedica, Inc.
Orthopedic · 73d
Cleared Apr 02, 1997
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
K961260
Biomet, Inc.
Orthopedic · 365d
Cleared Aug 29, 1996
SELECT SHOULDER COCR HUMERAL STEM COMPONENT
K962289
Intermedics Orthopedics
Orthopedic · 76d
Cleared Jul 12, 1996
HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
K954559
Howmedica Corp.
Orthopedic · 284d
Cleared May 30, 1995
INFINITY SHOULDER SYSTEM
K943908
Wrightmedicaltechnologyinc
Orthopedic · 292d
Cleared May 22, 1995
HEMI-SHOULDER PROSTHESIS
K950594
Encore Orthopedics, Inc.
Orthopedic · 102d
Cleared Jul 15, 1991
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
K911686
Depuy, Inc.
Orthopedic · 90d
Cleared Mar 12, 1991
EXACTECH HUMERAL SHOULDER PROSTHESIS
K905577
Exactech, Inc.
Orthopedic · 90d
Cleared Mar 12, 1991
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
K905580
Exactech, Inc.
Orthopedic · 90d
Cleared Jan 06, 1988
KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS
K874643
Kirschner Medical Corp.
Orthopedic · 54d
Cleared Nov 17, 1987
SELECT SHOULDER SYSTEM
K873679
Intermedics Orthopedics
Orthopedic · 64d
Cleared Oct 01, 1987
KIRSCHNER NEER-III PROXIMAL HUMERUS
K873073
Kirschner Medical Corp.
Orthopedic · 56d
Cleared Oct 06, 1982
101 NEER TYPE SHOULDER
K822771
Intermedics Orthopedics
Orthopedic · 22d
Cleared Sep 16, 1980
MONOSPHERICAL SHOULDER PROSTHESIS
K802123
Howmedica Corp.
Orthopedic · 12d