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510(k) K180808

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2018
Date Received
March 28, 2018
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

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  • K212297 — Omni Foot and Ankle Plating System (August 20, 2021)
  • 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)
  • K172260 — Omni Foot Plating System (November 6, 2017)

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  • 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)