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510(k) K251750

Trax EX Anchor by Trax Surgical, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2026
Date Received
June 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253618 — QuadLock™ Fixation System (January 6, 2026)
  • K253895 — Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm (December 30, 2025)