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510(k) K121437

MINI MAXLOCK EXTREME PLATING SYSTEM by Orthohelix Surgical Designs, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2012
Date Received
May 15, 2012
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.

  • K142148 — ORTHOHELIX STAPLE SYSTEM (August 21, 2014)
  • K141004 — INTRAOSSEOUS FIXATION SYSTEM (August 21, 2014)
  • 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)
  • K131324 — MAXTORQUE SCREW SYSTEM (May 31, 2013)
  • K123203 — MAXLOCK EXTREME SYSTEM MODEL MXL (December 14, 2012)
  • K122005 — MAXLOCK EXTREME SYSTEM (September 6, 2012)
  • K120165 — INTRAOSSEOUS FIXATION SYSTEM (April 17, 2012)

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