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510(k) K111041

MINI VARIABLE SYSTEM by Orthohelix Surgical Designs, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2011
Date Received
April 14, 2011
Clearance Type
Special
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 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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