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510(k) K073228

DC ULNAR SHORTENING SYSTEM by Orthopro, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2008
Date Received
November 15, 2007
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

Other clearances by Orthopro, LLC

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  • K113006 — I-FUSE HAMMER TOE SYSTEMS (May 25, 2012)
  • K093055 — CSTS SCREW (November 22, 2010)
  • 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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