Home / 510(k) Clearances / K982996

510(k) K982996

POLYMER OBL SB ANCHOR / SUTURE COMBINATION by Orthopaedic Biosystems, Ltd. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1999
Date Received
August 27, 1998
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)
  • 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)
  • K942889 — SB ANCHOR (August 25, 1995)

Other clearances for product code JDR

  • K250712 — Linkt Compression Staple System (May 14, 2025)
  • K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System (April 11, 2025)
  • K243742 — Arthrex DynaNite Nitinol Staples (January 31, 2025)
  • K243658 — TMC Compression Implant System (December 26, 2024)
  • K242415 — TMC Compression Implant System (September 6, 2024)
  • K240212 — COGNiTiON™ Staple System (February 23, 2024)
  • K232990 — A’TOMIC™ Nitinol Fixation System (January 12, 2024)
  • K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (December 4, 2023)
  • K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit (October 19, 2023)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)