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510(k) K132733

ORTHOHELIX SYNDESMOSIS FIXATION DEVICES by Orthohelix Surgical Designs, Inc. — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2014
Date Received
September 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Orthohelix Surgical Designs, Inc.

  • K141004 — INTRAOSSEOUS FIXATION SYSTEM (August 21, 2014)
  • K142148 — ORTHOHELIX STAPLE SYSTEM (August 21, 2014)
  • K141301 — MAXLOCK EXTREME ELBOW FRACTURE SYSTEM (July 11, 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)
  • K120165 — INTRAOSSEOUS FIXATION SYSTEM (April 17, 2012)

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