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510(k) K252657

Impact PEEK Union Nail System by Nvision Biomedical Technologies, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2025
Date Received
August 22, 2025
Clearance Type
Special
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 Nvision Biomedical Technologies, Inc.

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  • K250646 — Impact PEEK Union Nail System (June 11, 2025)
  • K250613 — SnapHammer Hammertoe Correction System (April 2, 2025)
  • K242896 — Caliber Intramedullary Fixation System (February 5, 2025)
  • K243231 — Trigon PEEK HA Wedges (November 8, 2024)
  • K240250 — 3D Printed PEEK Interbody System (September 17, 2024)
  • K231453 — SnapHammer Hammertoe Correction System (February 16, 2024)
  • K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation System (January 26, 2024)
  • K230853 — EARP Nerve Cuff Electrode (October 6, 2023)
  • K222015 — Integral Titanium Cervical Interbody (July 5, 2023)

Other clearances for product code HTY

  • K253325 — ZipToe™ Hammertoe Fusion System (December 29, 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)
  • K231339 — Tyber Medical Pin and Wire System (various) (July 6, 2023)