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510(k) K052754

WRIST FUSION PLATE by Dvo Extremity Solutions, LLC — Product Code LXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2005
Date Received
September 30, 2005
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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  • K090374 — STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 (March 11, 2009)
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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)