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510(k) K982963

POLYMER THREADED ANCHOR / SUTURE COMBINATION by Orthopaedic Biosystems, Ltd. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1998
Date Received
August 24, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
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)
  • 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)
  • K942889 — SB ANCHOR (August 25, 1995)

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