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510(k) K110592

3.7MM/5.0MM DYNAMIC LOCKING SCREW by Synthes USA — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2011
Date Received
March 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • 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)
  • 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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