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510(k) K121541

JAZZ SYSTEM by Implanet, S.A. — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2012
Date Received
May 24, 2012
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

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  • K191217 — JAZZ PF (August 2, 2019)
  • K182771 — ISS-JAZZ Screw System and JAZZ CAP SP (March 12, 2019)
  • K171881 — JAZZ Passer Band (August 8, 2017)
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  • K162764 — JAZZ FRAME SYSTEM (January 19, 2017)

Other clearances for product code JDQ

  • K243905 — Stitch Cerclage – Suture Tapes (August 14, 2025)
  • 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)