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510(k) K942889

SB ANCHOR by Orthopaedic Biosystems, Ltd. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1995
Date Received
June 20, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Orthopaedic Biosystems, Ltd.

  • K000797 — OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 (April 3, 2000)
  • K982996 — POLYMER OBL SB ANCHOR / SUTURE COMBINATION (March 4, 1999)
  • K983169 — POLYMER THREADED ANCHOR (December 16, 1998)
  • K982963 — POLYMER THREADED ANCHOR / SUTURE COMBINATION (November 20, 1998)
  • K972326 — PEBA ANCHOR/SUTURE COMBINATION (February 6, 1998)
  • K963420 — CANCELLOUS SCREW WASHER (November 15, 1996)
  • K963432 — GUIDE WIRES FOR CANNULATED SCREWS (November 13, 1996)
  • K963433 — THREADED FIXATION PIN (November 6, 1996)
  • K962779 — COMPRESSION SCREW (August 23, 1996)
  • K951451 — PEBA ANCHOR (MULTIPLE SIZES) (October 31, 1995)

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