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510(k) K963420

CANCELLOUS SCREW WASHER by Orthopaedic Biosystems, Ltd. — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1996
Date Received
August 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
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)
  • 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)
  • K942889 — SB ANCHOR (August 25, 1995)

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