Medical Device Manufacturer · US , Port Huron , MI

Biologically Oriented Prostheses - FDA 510(k) Cleared Devices

9 submissions · 7 cleared · Since 1995

9

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biologically Oriented Prostheses Orthopedic ✕

9 devices

1-9 of 9

Cleared Oct 30, 2000

WUJIN #3 TIBIAL NAIL

Orthopedic · 90d

Cleared Sep 22, 1999

BIOPRO RIMMED ACETABULAR COMPOMENT

Orthopedic · 90d

Cleared Feb 03, 1997

RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT

Orthopedic · 88d

Cleared Oct 03, 1996

HORIZON HIP SYSTEM

Orthopedic · 79d

Cleared Aug 08, 1996

TOWNLEY TOTAL ELBOW SYSTEM

Orthopedic · 223d

Cleared Jan 18, 1996

BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD

Orthopedic · 93d

Cleared Dec 28, 1995

TOWNLEY ALL POLY ACETABULAR CUP

Orthopedic · 196d

Cleared Sep 27, 1995

BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD

Orthopedic · 89d

Cleared Jun 19, 1995

VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED

Orthopedic · 87d