Medical Device Manufacturer · US , Scotsdale , AZ

Orthopaedic Biosystems, Ltd. - FDA 510(k) Cleared Devices

11 submissions · 9 cleared · Since 1995

Recent clearances: POLYMER OBL SB ANCHOR / SUTURE COMBINATION, POLYMER THREADED ANCHOR, POLYMER THREADED ANCHOR / SUTURE COMBINATION

11

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orthopaedic Biosystems, Ltd. Orthopedic ✕

11 devices

1-11 of 11

Cleared Apr 03, 2000

OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01

Orthopedic · 21d

Cleared Mar 04, 1999

POLYMER OBL SB ANCHOR / SUTURE COMBINATION

Orthopedic · 189d

Cleared Dec 16, 1998

POLYMER THREADED ANCHOR

Orthopedic · 97d

Cleared Nov 20, 1998

POLYMER THREADED ANCHOR / SUTURE COMBINATION

Orthopedic · 88d

Cleared Feb 06, 1998

PEBA ANCHOR/SUTURE COMBINATION

Orthopedic · 228d

Cleared Nov 15, 1996

CANCELLOUS SCREW WASHER

Orthopedic · 77d

Cleared Nov 13, 1996

GUIDE WIRES FOR CANNULATED SCREWS

Orthopedic · 75d

Cleared Nov 06, 1996

THREADED FIXATION PIN

Orthopedic · 68d

Cleared Aug 23, 1996

COMPRESSION SCREW

Orthopedic · 37d

Cleared Oct 31, 1995

PEBA ANCHOR (MULTIPLE SIZES)

Orthopedic · 216d

Cleared Aug 25, 1995

Orthopedic · 431d