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 DePuy Orthopaedics, Inc..

71
Total
71
Cleared
120d
Avg days
1979
Since
71 devices
49–71 of 71
Cleared Feb 04, 2000
ACUMED MODULAR SHOULDER SYSTEM
K992525
Acu Med, Inc.
Orthopedic · 191d
Cleared Oct 15, 1999
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
K992394
Endotec, Inc.
Orthopedic · 88d
Cleared Feb 05, 1999
HOWMEDICA HUMERAL INTERCALARY SYSTEM
K984202
Howmedica, Inc.
Orthopedic · 73d
Cleared Oct 05, 1998
OTI MODULAR SHOULDER SYSTEM
K982886
Osteoimplant Technology, Inc.
Orthopedic · 49d
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 Oct 14, 1994
ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM
K935593
Biodynamic Technologies, Inc.
Orthopedic · 329d
Cleared Oct 21, 1991
LIMA RPS SHOULDER
K913282
Turnkey Intergration USA, Inc.
Orthopedic · 89d
Cleared Jul 26, 1991
BONE NAIL, KUNTSCHER
K911982
International Hospital Supply Co.
Orthopedic · 84d
Cleared Jul 15, 1991
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
K911686
Depuy, Inc.
Orthopedic · 90d
Cleared Jun 28, 1991
TEMPERLITE(TM) SAW BLADE
K911902
Sierra Surgical, Inc.
Orthopedic · 63d
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
Cleared Mar 18, 1980
NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS
K800494
Depuy, Inc.
Orthopedic · 14d
Cleared Sep 28, 1979
REXTON HS(HEARING SYSTEM)
K791548
Argosy Intl. (Usa), Inc.
Orthopedic · 46d