Home / 510(k) Clearances / K090289

510(k) K090289

CLAVICLE PLATING SYSTEM by Orthohelix Surgical Designs, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2009
Date Received
February 5, 2009
Clearance Type
Traditional
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)
  • 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)

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)