Medical Device Manufacturer · US , Mchenry , IL

Danek Medical, Inc.

56 submissions · 47 cleared · Since 1981
56
Total
47
Cleared
0
Denied

Danek Medical, Inc. — FDA 510(k) Submissions

Danek Medical, Inc. has submitted 56 FDA 510(k) premarket notifications since 1981, of which 47 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Appliance, Fixation, Spinal Interlaminal, Arthroscope, Appliance, Fixation, Spinal Intervertebral Body, Orthosis, Spinal Pedicle Fixation, Orthosis, Spondylolisthesis Spinal Fixation . Use the specialty filter in the sidebar to narrow results.

56 devices
1–25 of 56
BONE GRAFT WASHER, MODEL 9090114 - 9090118
K994122 · KWQ Appliance, Fixation,... · Orthopedic
Feb 2000 73d
CD HORIZON SPINAL SYSTEM
K993810 · MNH Orthosis,... · Orthopedic
Feb 2000 85d
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K993855 · KWQ Appliance, Fixation,... · Orthopedic
Dec 1999 30d
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
K991528 · MNH Orthosis,... · Orthopedic
May 1999 25d
MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K990603 · KWQ Appliance, Fixation,... · Orthopedic
Mar 1999 15d
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K982875 · KWQ Appliance, Fixation,... · Orthopedic
Jan 1999 158d
MODIFICATION OF TSRH SPINAL SYSTEM
K984522 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Jan 1999 16d
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982154 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Jul 1998 24d
TOWNLEY PEDICLE SCREW PLATING SYSTEM
K970599 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Mar 1998 395d
SPINE FIXATION
K943827 · MNH Orthosis,... · Orthopedic
Feb 1996 558d
INCLUSIVE ENDOSCOPE
K943356 · HRX Arthroscope · Orthopedic
May 1995 302d
DANEKSCOPE OPTI-PROBE
K943676 · HRX Arthroscope · Orthopedic
Nov 1994 118d
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON
K933205 · KWP Appliance, Fixation,... · Orthopedic
May 1994 307d
SOFAMOR ORTHOPAEDIC INSTRUMENTS
K933242 · LXH Orthopedic Manual... · Orthopedic
Jan 1994 210d
DANEKSCOPE AND ACCESSORIES
K911729 · HRX Arthroscope · Orthopedic
Apr 1993 719d
DANEK SPINALSCOPE
K901692 · HRX Arthroscope · Orthopedic
Feb 1992 674d
TSRH VARIABLE ANGLE SACRAL SCREW
K904243 · KWP Appliance, Fixation,... · Orthopedic
Jan 1992 495d
SONGER(TM) CABLE SYSTEM
K913735 · JDQ Cerclage, Fixation · Orthopedic
Nov 1991 90d
RAY SACRAL FIXATION SYSTEM
K904520 · KWP Appliance, Fixation,... · Orthopedic
Oct 1991 387d
CROSSLINK PLATE
K911307 · KWP Appliance, Fixation,... · Orthopedic
Oct 1991 213d
DANEK SACRAL HOOK, MODIFICATION
K911379 · KWP Appliance, Fixation,... · Orthopedic
Sep 1991 168d
T-BOLT AND NUT
K911306 · HTN Washer, Bolt Nut · Orthopedic
Sep 1991 169d
TSRH OPEN HEAD BONE SCREW
K911319 · KWP Appliance, Fixation,... · Orthopedic
Sep 1991 164d
MICROSURGICAL INSTRUMENTS
K911300 · HRX Arthroscope · Orthopedic
Apr 1991 11d
TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)
K901005 · KWP Appliance, Fixation,... · Orthopedic
Dec 1990 283d
Filters