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510(k) K250712

Linkt Compression Staple System by Trax Surgical — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2025
Date Received
March 10, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Trax Surgical

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  • K230946 — Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compres (September 15, 2023)

Other clearances for product code JDR

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  • K243742 — Arthrex DynaNite Nitinol Staples (January 31, 2025)
  • K243658 — TMC Compression Implant System (December 26, 2024)
  • K242415 — TMC Compression Implant System (September 6, 2024)
  • K240212 — COGNiTiON™ Staple System (February 23, 2024)
  • K232990 — A’TOMIC™ Nitinol Fixation System (January 12, 2024)
  • K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (December 4, 2023)
  • K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit (October 19, 2023)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)
  • K232387 — Treace Medical Concepts (TMC) Compression Implant System (August 28, 2023)