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510(k) K030198

HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM by Hand Innovations, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2003
Date Received
January 21, 2003
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 Hand Innovations, Inc.

  • K061748 — FRAGMENT PLATE SYSTEM (July 17, 2006)
  • K060864 — MULTIDIRECTIONAL THREADED PEG (April 28, 2006)
  • K060294 — DIAPHYSEAL PLATE (March 22, 2006)
  • K060290 — SHOULDER FIXATION SYSTEM (February 27, 2006)
  • K052294 — SHOULDER NAIL PLATE (October 21, 2005)
  • K052248 — DORSAL NAIL PLATE, ANATOMICAL (September 14, 2005)
  • K051728 — MODIFICATION TO SHOULDER FIXATION SYSTEM (July 20, 2005)
  • K050932 — DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM (April 26, 2005)
  • K042059 — SHOULDER FIXATION SYSTEM (September 30, 2004)
  • K041157 — MODIFICATION TO SMALL BONE FIXATION SYSTEM (July 30, 2004)

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  • 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)