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510(k) K161417

DePuy Synthes MAXFRAME Multi-Axial Correction System by Synthes USA, LLC — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2016
Date Received
May 23, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • 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)

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