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510(k) K212297

Omni Foot and Ankle Plating System by Extremity Medical, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2021
Date Received
July 22, 2021
Clearance Type
Special
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 Extremity Medical, LLC

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  • K211261 — Axis Charcot Fixation System (May 28, 2021)
  • K201556 — Intraosseous Fixation System (July 8, 2020)
  • K191525 — KinematX Total Wrist Arthroplasty System (March 4, 2020)
  • K192592 — Axis Plating System (November 21, 2019)
  • K181067 — AlignX Ankle Fusion System (May 23, 2018)
  • K180808 — Omni Foot Plating System (May 22, 2018)
  • K172260 — Omni Foot Plating System (November 6, 2017)

Other clearances for product code HRS

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  • 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)