Danek Medical, Inc. - FDA 510(k) Cleared Devices
56
Total
47
Cleared
0
Denied
56 devices
Cleared
Dec 10, 1990
KNIGHT SACRAL SCREW
Orthopedic
168d
Cleared
Dec 05, 1990
TSRH OFFSET AND SIDE-LOADING HOOKS
Orthopedic
126d
Cleared
Nov 05, 1990
TSRH SACRAL L-CONNECTOR
Orthopedic
215d
Cleared
Sep 10, 1990
STERNOTOMY CABLE, SONGER CABLE SYSTEM
Orthopedic
28d
Cleared
Sep 06, 1990
OLIVE K-WIRES
Orthopedic
63d
Cleared
Aug 21, 1990
DANEK SACRAL HOOK
Orthopedic
138d
Cleared
Aug 09, 1990
CHIBA SPINAL SYSTEM
Orthopedic
301d
Cleared
Jun 14, 1990
DANEK PRECISION ROD SET
Orthopedic
227d
Cleared
Feb 26, 1990
AXIAL AND OFFSET CROSSLINK PLATES
Orthopedic
88d
Cleared
Jan 30, 1990
HSC UNIT ROD
Orthopedic
70d
Cleared
Jan 04, 1990
LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET
Orthopedic
351d
Cleared
Aug 28, 1989
DANEK WRIST FIXATOR
Orthopedic
180d
Cleared
Jul 25, 1989
SONGER WIRING SYSTEM
Orthopedic
103d
Cleared
Jun 13, 1989
DANEK RING FIXATOR (DRF)
Orthopedic
117d
Cleared
Jan 24, 1989
DANEK IRRIGATING BURR (DIB) SET
General & Plastic Surgery
14d
Cleared
Jul 22, 1985
MACULAR FUNCTION ANALYZER
Ophthalmic
340d
Cleared
Jan 21, 1983
SIDE RAIL PADS
General Hospital
35d
Cleared
Jan 14, 1983
VARIOUS ARM SLING
Physical Medicine
28d
Cleared
Jan 14, 1983
CLAVICAL STRAP
Physical Medicine
28d
Cleared
Jan 14, 1983
A.C. SPLINT
Physical Medicine
28d
Cleared
Jan 14, 1983
OVERHEAD ARM SLINGS
Physical Medicine
28d
Cleared
Jan 14, 1983
VARIOUS SUPPORTS AND SPLINTS
Physical Medicine
28d
Cleared
Jan 14, 1983
TRACTION ACCESSORIES
Neurology
28d
Cleared
Jan 14, 1983
HOT/COLD PACK HOLDERS
Physical Medicine
28d
Cleared
Jan 14, 1983
WHEELCHAIR PATIENT RESTRAINTS
Physical Medicine
28d