FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

56 results for "Danek Medical, Inc."
1–24 of 56
Search insights Median review: 88d Cleared: 100% Top manufacturer: Danek Medical, Inc. Lead specialty: Orthopedic
Cleared Feb 18, 2000
BONE GRAFT WASHER, MODEL 9090114 - 9090118
K994122 · KWQ
Danek Medical, Inc.
Orthopedic · 73d
Cleared Feb 03, 2000
CD HORIZON SPINAL SYSTEM
K993810 · MNH
Danek Medical, Inc.
Orthopedic · 85d
Cleared Dec 15, 1999
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K993855 · KWQ
Danek Medical, Inc.
Orthopedic · 30d
Cleared May 28, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
K991528 · MNH
Danek Medical, Inc.
Orthopedic · 25d
Cleared Mar 10, 1999
MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K990603 · KWQ
Danek Medical, Inc.
Orthopedic · 15d
Cleared Jan 19, 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K982875 · KWQ
Danek Medical, Inc.
Orthopedic · 158d
Cleared Jan 06, 1999
MODIFICATION OF TSRH SPINAL SYSTEM
K984522 · MNI
Danek Medical, Inc.
Orthopedic · 16d
Cleared Jul 13, 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982154 · MNI
Danek Medical, Inc.
Orthopedic · 24d
Cleared Mar 20, 1998
TOWNLEY PEDICLE SCREW PLATING SYSTEM
K970599 · MNI
Danek Medical, Inc.
Orthopedic · 395d
Cleared Feb 14, 1996
SPINE FIXATION
K943827 · MNH
Danek Medical, Inc.
Orthopedic · 558d
Cleared May 10, 1995
INCLUSIVE ENDOSCOPE
K943356 · HRX
Danek Medical, Inc.
Orthopedic · 302d
Cleared Nov 21, 1994
DANEKSCOPE OPTI-PROBE
K943676 · HRX
Danek Medical, Inc.
Orthopedic · 118d
Cleared May 04, 1994
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON
K933205 · KWP
Danek Medical, Inc.
Orthopedic · 307d
Cleared Jan 28, 1994
SOFAMOR ORTHOPAEDIC INSTRUMENTS
K933242 · LXH
Danek Medical, Inc.
Orthopedic · 210d
Cleared Apr 05, 1993
DANEKSCOPE AND ACCESSORIES
K911729 · HRX
Danek Medical, Inc.
Orthopedic · 719d
Cleared Feb 14, 1992
DANEK SPINALSCOPE
K901692 · HRX
Danek Medical, Inc.
Orthopedic · 674d
Cleared Jan 22, 1992
TSRH VARIABLE ANGLE SACRAL SCREW
K904243 · KWP
Danek Medical, Inc.
Orthopedic · 495d
Cleared Nov 18, 1991
SONGER(TM) CABLE SYSTEM
K913735 · JDQ
Danek Medical, Inc.
Orthopedic · 90d
Cleared Oct 25, 1991
RAY SACRAL FIXATION SYSTEM
K904520 · KWP
Danek Medical, Inc.
Orthopedic · 387d
Cleared Oct 24, 1991
CROSSLINK PLATE
K911307 · KWP
Danek Medical, Inc.
Orthopedic · 213d
Cleared Sep 11, 1991
DANEK SACRAL HOOK, MODIFICATION
K911379 · KWP
Danek Medical, Inc.
Orthopedic · 168d
Cleared Sep 10, 1991
T-BOLT AND NUT
K911306 · HTN
Danek Medical, Inc.
Orthopedic · 169d
Cleared Sep 06, 1991
TSRH OPEN HEAD BONE SCREW
K911319 · KWP
Danek Medical, Inc.
Orthopedic · 164d
Cleared Apr 05, 1991
MICROSURGICAL INSTRUMENTS
K911300 · HRX
Danek Medical, Inc.
Orthopedic · 11d