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510(k) K110895

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS by Ortho Solutions Limited — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2011
Date Received
March 30, 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

Other clearances by Ortho Solutions Limited

  • K141784 — ORTHO SOLUTIONS ULTOS PLATING SYSTEM (July 23, 2014)
  • K121575 — OXFORD ANKLE FUSION NAIL(AFN) SYSTEM (September 14, 2012)
  • K120360 — ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS (May 29, 2012)
  • K111678 — ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS (February 7, 2012)
  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (January 20, 2011)

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