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510(k) K073135

SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS by Synthes (Usa) — Product Code LXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2008
Date Received
November 7, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K060864 — MULTIDIRECTIONAL THREADED PEG (April 28, 2006)
  • K060403 — PTA (PROGRESSIVE TIBIAL ALIGNMENT) (March 28, 2006)
  • K060290 — SHOULDER FIXATION SYSTEM (February 27, 2006)
  • K052754 — WRIST FUSION PLATE (October 27, 2005)