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510(k) K120165

INTRAOSSEOUS FIXATION SYSTEM by Orthohelix Surgical Designs, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2012
Date Received
January 19, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Orthohelix Surgical Designs, Inc.

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  • K132733 — ORTHOHELIX SYNDESMOSIS FIXATION DEVICES (January 3, 2014)
  • K132591 — MAXLOCK EXTREME SYSTEM (September 17, 2013)
  • K130832 — ORTHOHELIX STAPLE SYSTEM (August 15, 2013)
  • K131324 — MAXTORQUE SCREW SYSTEM (May 31, 2013)
  • K123203 — MAXLOCK EXTREME SYSTEM MODEL MXL (December 14, 2012)
  • K122005 — MAXLOCK EXTREME SYSTEM (September 6, 2012)
  • K121437 — MINI MAXLOCK EXTREME PLATING SYSTEM (June 13, 2012)

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