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510(k) K120360

ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS by Ortho Solutions Limited — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2012
Date Received
February 6, 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

Other clearances by Ortho Solutions Limited

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  • K121575 — OXFORD ANKLE FUSION NAIL(AFN) SYSTEM (September 14, 2012)
  • K111678 — ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS (February 7, 2012)
  • K110895 — ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS (December 19, 2011)
  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (January 20, 2011)

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