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510(k) K181607

Thorecon Rigid Fixation System by A & E Medical Corporation — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2018
Date Received
June 19, 2018
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 A & E Medical Corporation

  • K193479 — Sternal Cable System (March 23, 2020)
  • K180582 — Sternal Cable System (May 31, 2018)
  • K173579 — Thorecon™ Fixation System (February 12, 2018)

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)