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FDA 510(k)

Impact PEEK Union Nail System

K-Number: K250646 · 2025-06-11

ApplicantNvision Biomedical Technologies
Decision Date2025-06-11
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Impact PEEK Union Nail System is a medical device manufactured by Nvision Biomedical Technologies. It received FDA 510(k) clearance on 2025-06-11 under approval number K250646. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Impact PEEK Union Nail System?

Impact PEEK Union Nail System is a medical device that received FDA 510(k) clearance on 2025-06-11. It is manufactured by Nvision Biomedical Technologies. The 510(k) number is K250646.

When was Impact PEEK Union Nail System approved by the FDA?

Impact PEEK Union Nail System received FDA 510(k) clearance on 2025-06-11, under approval number K250646.

What company makes Impact PEEK Union Nail System?

Impact PEEK Union Nail System is manufactured by Nvision Biomedical Technologies.

What is the FDA product code for Impact PEEK Union Nail System?

The FDA product code for Impact PEEK Union Nail System is HTY.

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Related PubMed Literature

PMID: 41570090 Mapping the regulatory landscape for environmental sustainability of medical device practices within the European Union. European journal of public health (2026) PMID: 41454392 Global market and supply chain implications of the European Union medical device regulation 2017/745 as amended by 2023/607. BMC health services research (2025) PMID: 40866856 Prognostic value of nutritional risk assessment indices in patients with digestive system tumors. BMC cancer (2025) PMID: 40498444 Assessing the Impact of End-of-Life Processing on Reusable Medical Devices. Biomedical instrumentation & technology (2025)

Other Devices by Nvision Biomedical Technologies

K243231Trigon PEEK HA Wedges K234116Trigon Trigon HA Stand-Alone Wedge Fixation System K242896Caliber Intramedullary Fixation System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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