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510(k) K110354

4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM by Synthes USA — Product Code JDP

K110354 is an FDA 510(k) premarket notification submitted by Synthes USA for the device "4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 4, 2011. The device falls under product code JDP (Condylar Plate Fixation Implant), a Class II device regulated under 21 CFR 888.3030. Synthes USA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2011
Date Received
February 7, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condylar Plate Fixation Implant
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)
  • K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TI (July 6, 2012)
  • 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)

Other clearances for product code JDP

  • K162124 — Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle (March 29, 2017)

FDA data resources