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510(k) K140463

INTEGRA EXTERNAL FIXATION SYSTEM by Ascension Orthopedic — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2014
Date Received
February 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K112278 — ASCENSION NUGRIP CMC IMPLANT (November 4, 2011)
  • K111799 — NUGAIT(TM) SUBTALAR IMPLANT SYSTEM (August 19, 2011)

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