Medical Device Manufacturer · US , Mchenry , IL

Danek Medical, Inc. - FDA 510(k) Cleared Devices

56 submissions · 47 cleared · Since 1981

56

Total

47

Cleared

0

Denied

40 devices

26-40 of 40

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

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

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 14, 1983

Orthopedic · 28d