Home / 510(k) Clearances / K013424

510(k) K013424

INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND by Hand Innovations, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2001
Date Received
October 15, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
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)

Other clearances for product code HTY

  • K253325 — ZipToe™ Hammertoe Fusion System (December 29, 2025)
  • K252657 — Impact PEEK Union Nail System (September 19, 2025)
  • K250315 — RONAVIS – FX (FX-001) (August 1, 2025)
  • K251362 — PediFlex™ Flexible Nail System (June 24, 2025)
  • K250646 — Impact PEEK Union Nail System (June 11, 2025)
  • K241014 — Biomet Kirschner Wires (K-Wires) (May 22, 2024)
  • K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimm (December 1, 2023)
  • K231147 — Hammerdesis™ Interphalangeal Fusion System (September 14, 2023)
  • K230750 — OSSIOfiber® Cannulated Trimmable Fixation Nail (September 13, 2023)
  • K231905 — Electro-Spec Steri-Caps (August 14, 2023)