Impact PEEK Union Nail System— 510(k) K250646

Name: FDA 510(k) clearance K250646
Creator: U.S. Food and Drug Administration
Published: 2025-06-11

Substantially Equivalent

Nvision Biomedical Technologies

FDA 510(k) clearance K250646 for Impact PEEK Union Nail System, Substantially Equivalent on 2025-06-11. Applicant: Nvision Biomedical Technologies. Device class: 2.

Clearance details

Applicant: Nvision Biomedical Technologies
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2025-03-04
Decision date: 2025-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTY

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K262722 — Primal K-Wire (P99-193-1410)2026-08-28
K253325 — ZipToe Hammertoe Fusion System2025-12-29
K252657 — Impact PEEK Union Nail System2025-09-19
K250315 — RONAVIS FX (FX-001)2025-08-01
K251362 — PediFlex Flexible Nail System2025-06-24

More clearances from Nvision Biomedical Technologies

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K242896 — Caliber Intramedullary Fixation System2025-02-05
K243231 — Trigon PEEK HA Wedges2024-11-08
K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation System2024-01-26

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.