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510(k) K182783

DePuy Synthes Trauma Orthopedic Nail Implants by DePuy Synthes — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2018
Date Received
October 1, 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

Other clearances by DePuy Synthes

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  • K233254 — TELIGEN System Navigation Ready Instruments (June 14, 2024)
  • K233665 — DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragme (March 21, 2024)
  • K231922 — DEPUY SYNTHES MAXFRAME AUTOSTRUT System (July 26, 2023)
  • K221809 — DePuy Synthes 3.5mm Intrapelvic Acetabular System (September 20, 2022)
  • K213563 — DePuy Synthes Radial Head Replacement System (March 18, 2022)
  • K211051 — DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LC (June 2, 2021)
  • K203414 — DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Cla (December 16, 2020)

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)