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510(k) K131324

MAXTORQUE SCREW SYSTEM by Orthohelix Surgical Designs, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2013
Date Received
May 8, 2013
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 Orthohelix Surgical Designs, Inc.

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  • K141301 — MAXLOCK EXTREME ELBOW FRACTURE SYSTEM (July 11, 2014)
  • K132733 — ORTHOHELIX SYNDESMOSIS FIXATION DEVICES (January 3, 2014)
  • K132591 — MAXLOCK EXTREME SYSTEM (September 17, 2013)
  • K130832 — ORTHOHELIX STAPLE SYSTEM (August 15, 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)
  • K120165 — INTRAOSSEOUS FIXATION SYSTEM (April 17, 2012)

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