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510(k) K914374

OSTEO CERCLAGE WIRE by Osteo AG — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1991
Date Received
October 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

Other clearances by Osteo AG

  • K933340 — OSTEO INTERLOCKING-COMPRESSION NAIL (June 30, 1994)
  • K922193 — OSTEO KIRSCHNER WIRE (July 23, 1992)
  • K922195 — OSTEO FEMORAL NAIL (July 23, 1992)
  • K922194 — OSTEO STEINMANN PIN (July 23, 1992)
  • K922196 — OSTEO TIBIA NAIL (July 23, 1992)
  • K920149 — OSTEO EX-FI-RE (April 9, 1992)
  • K920037 — OSTEO COMPRESSION HIP SCREW (March 11, 1992)
  • K913559 — OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR (November 7, 1991)

Other clearances for product code JDQ

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  • K243344 — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape C (February 20, 2025)
  • K232733 — Mbrace Cable (May 3, 2024)
  • K233949 — ACCORD Cable System (March 13, 2024)
  • K232986 — VariTrax Sternal CircumFixation System (January 30, 2024)
  • K230976 — Arthrex Radiopaque FiberTape Cerclage sutures (August 24, 2023)
  • K231333 — STRETTO™ Cable System (August 4, 2023)
  • K220765 — HS Fiber Cerclage (July 26, 2023)
  • K221795 — STERN FIX Sternal Stabilization System (October 19, 2022)
  • K211613 — Stern Fix Sternal Stabilization System (January 19, 2022)