Home / 510(k) Clearances / K132591

510(k) K132591

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2013
Date Received
August 19, 2013
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.

  • K141004 — INTRAOSSEOUS FIXATION SYSTEM (August 21, 2014)
  • K142148 — ORTHOHELIX STAPLE SYSTEM (August 21, 2014)
  • K141301 — MAXLOCK EXTREME ELBOW FRACTURE SYSTEM (July 11, 2014)
  • K132733 — ORTHOHELIX SYNDESMOSIS FIXATION DEVICES (January 3, 2014)
  • 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)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)