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510(k) K253906

Xpert Hand by Newclip Technics — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2026
Date Received
December 5, 2025
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 Newclip Technics

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  • K250155 — Xpert Knee (April 23, 2025)
  • K243912 — Newclip Patient-matched instrumentation non sterile PSI (February 13, 2025)
  • K240415 — Newclip Patient-matched instrumentation non sterile PSI (November 7, 2024)
  • K241539 — Activmotion S (July 30, 2024)
  • K221615 — Newclip Patient-matched instrumentation non sterile PSI (October 25, 2023)
  • K221395 — Footmotion Plating System (July 1, 2022)
  • K202803 — Activmotion S DTO (December 16, 2021)
  • K213214 — Xpert Wrist (November 24, 2021)
  • K202307 — Activ Fuse (November 17, 2020)

Other clearances for product code HRS

  • 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)
  • K252807 — Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates (January 12, 2026)