Medical Device Manufacturer · US , San Mateo , CA

Osteotech, Inc. - FDA 510(k) Cleared Devices

24 submissions · 21 cleared · Since 1985
24
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osteotech, Inc. Orthopedic
19 devices
1-19 of 19
Cleared Oct 16, 2008
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM...
K082615 · MQV
Orthopedic · 37d
Cleared Jul 22, 2008
PLEXUR M
K081227 · MQV
Orthopedic · 83d
Cleared Apr 21, 2008
PLEXUR-P
K080511 · MQV
Orthopedic · 56d
Cleared Mar 03, 2008
PLEXUR M
K073405 · MQV
Orthopedic · 90d
Cleared Feb 07, 2007
PLEXUR P
K061982 · MBP
Orthopedic · 209d
Cleared Dec 16, 2005
GRAFTON DBM
K051195 · MBP
Orthopedic · 220d
Cleared Dec 16, 2005
GRAFTCAGE TLX
K051781 · MQP
Orthopedic · 168d
Cleared Dec 05, 2005
VIAGRAF DBM PASTE
K043209 · MBP
Orthopedic · 381d
Cleared Dec 01, 2005
GRAFTCAGE ACX
K053080 · MQP
Orthopedic · 29d
Cleared Nov 23, 2005
GRAFTON PLUS DBM PASTE
K043048 · MBP
Orthopedic · 384d
Cleared Oct 16, 2001
VBR
K012254 · MQP
Orthopedic · 90d
Cleared Jan 04, 2001
VERTEBRAL BODY REPLACEMENT
K003155 · MQP
Orthopedic · 86d
Cleared Nov 24, 2000
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
K003384 · MNH
Orthopedic · 24d
Cleared Nov 19, 1999
VERSALOK LOW BACK FIXATION SYSTEM
K992885 · KWP
Orthopedic · 84d
Cleared Jul 23, 1999
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K991586 · KWP
Orthopedic · 77d
Cleared Jan 08, 1998
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K973868 · KWP
Orthopedic · 90d
Cleared Jun 18, 1997
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K971289 · KWP
Orthopedic · 72d
Cleared Feb 09, 1996
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K955173 · KWP
Orthopedic · 88d
Cleared Jun 22, 1995
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
K950652 · HWC
Orthopedic · 129d
Filters