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Orthopaedic Biosystems, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K000797OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01April 3, 2000
K982996POLYMER OBL SB ANCHOR / SUTURE COMBINATIONMarch 4, 1999
K983169POLYMER THREADED ANCHORDecember 16, 1998
K982963POLYMER THREADED ANCHOR / SUTURE COMBINATIONNovember 20, 1998
K972326PEBA ANCHOR/SUTURE COMBINATIONFebruary 6, 1998
K963420CANCELLOUS SCREW WASHERNovember 15, 1996
K963432GUIDE WIRES FOR CANNULATED SCREWSNovember 13, 1996
K963433THREADED FIXATION PINNovember 6, 1996
K962779COMPRESSION SCREWAugust 23, 1996
K951451PEBA ANCHOR (MULTIPLE SIZES)October 31, 1995
K942889SB ANCHORAugust 25, 1995
K932041XANCHOR SUTURE ATTACHMENT DEVICEAugust 12, 1994
K922788BIOACTION LOW PROFILE SCREW SYSTEMMarch 12, 1993
K911552ANATOMIC TOE SYSTEMJune 28, 1991