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510(k) K121601

SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE by Synthes USA — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2012
Date Received
June 1, 2012
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 Synthes USA

  • K161417 — DePuy Synthes MAXFRAME Multi-Axial Correction System (November 10, 2016)
  • K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM (March 30, 2015)
  • K112030 — SYNTHES RADIAL HEAD PROSTHESIS SYSTEM (June 19, 2012)
  • K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM (June 18, 2012)
  • K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMER (May 8, 2012)
  • K120070 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (March 21, 2012)
  • K120083 — SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) (February 8, 2012)
  • K110592 — 3.7MM/5.0MM DYNAMIC LOCKING SCREW (July 25, 2011)
  • K110125 — 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM (April 21, 2011)
  • K110354 — 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM (March 4, 2011)

Other clearances for product code HRS

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  • 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)