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510(k) K120083

SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) by Synthes USA — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2012
Date Received
January 11, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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  • 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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