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510(k) K111799

NUGAIT(TM) SUBTALAR IMPLANT SYSTEM by Ascension Orthopedic — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2011
Date Received
June 27, 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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  • K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (April 9, 2012)
  • K112278 — ASCENSION NUGRIP CMC IMPLANT (November 4, 2011)

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