Medical Device Manufacturer · US , Barberton , OH

Theken Surgical,Llc - FDA 510(k) Cleared Devices

6 submissions · 4 cleared · Since 1998

6

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Theken Surgical,Llc Orthopedic ✕

6 devices

1-6 of 6

Cleared May 17, 2005

THEKEN REVEAL VBR SYSTEM

Orthopedic · 126d

Cleared Feb 20, 2004

THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM

Orthopedic · 232d

Cleared Oct 29, 2001

THEKEN LARGE CEMENT RESTRICTOR

Orthopedic · 89d

Cleared Oct 17, 2001

THEKEN SMALL CEMENT RESTRICTOR

Orthopedic · 90d

Cleared May 16, 2001

Orthopedic · 89d

Cleared Dec 30, 1998

BODYFORM THORACO-LUMBAR FIXATION SYSTEM

Orthopedic · 76d