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510(k) K122936

ANKLE TRAUMA SYSTEM by Orthopro, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2013
Date Received
September 24, 2012
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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  • K070555 — ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES (July 13, 2007)
  • K071243 — METAL HEMI IMPLANT (May 23, 2007)
  • K062908 — ORTHROPRO HEMI TOE (November 13, 2006)

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