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510(k) K243905

Stitch Cerclage – Suture Tapes by GM Dos Reis Industria e Comercio Ltda. — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2025
Date Received
December 19, 2024
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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  • K230397 — Cut Screw - Percutaneous Compression Screw (June 12, 2023)
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Other clearances for product code JDQ

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  • 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)
  • K201497 — EVOS Cabling System (October 28, 2020)