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510(k) K030256

ISO-ELASTIC CERCLAGE SYSTEM by Kinamed, Inc. — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2003
Date Received
January 24, 2003
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 Kinamed, Inc.

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  • K050897 — NAVIPRO SHOULDER SOFTWARE MODULE (May 24, 2005)
  • K033668 — NAVIPRO KNEE SOFTWARE MODULE (March 11, 2004)
  • K032950 — GEM INSET PATELLAR COMPONENT (December 19, 2003)
  • K020764 — NAVIPRO (June 3, 2002)
  • K013982 — KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT (May 21, 2002)
  • K010101 — GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM (May 17, 2001)
  • K003347 — ORTHOPILOT (February 23, 2001)
  • K994214 — GEM KNEE SYSTEM (July 19, 2000)

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)