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510(k) K131360

INTEGRA TITANIUM BONE WEDGE by Ascension Orthopedic — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2013
Date Received
May 13, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
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)
  • K111799 — NUGAIT(TM) SUBTALAR IMPLANT SYSTEM (August 19, 2011)

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