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510(k) K233863

TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- by TriMed, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2024
Date Received
December 6, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by TriMed, Inc.

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  • K251134 — RipCord (July 11, 2025)
  • K251945 — TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) (July 10, 2025)
  • K250929 — TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar (June 26, 2025)
  • K250935 — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal (May 22, 2025)
  • K243943 — TriMed® Compression Screws (April 10, 2025)
  • K250948 — TriMed Fusion Cup System (April 8, 2025)
  • K243999 — TriMed Ankle Fixation System (March 19, 2025)
  • K243987 — TriMed Elbow and Forearm System (March 19, 2025)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)