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FDA 510(k)

enHAnce PEEK Bunion System

K-Number: K253718 · 2026-04-01

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2026-04-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

enHAnce PEEK Bunion System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2026-04-01 under approval number K253718. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the enHAnce PEEK Bunion System?

enHAnce PEEK Bunion System is a medical device that received FDA 510(k) clearance on 2026-04-01. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K253718.

When was enHAnce PEEK Bunion System approved by the FDA?

enHAnce PEEK Bunion System received FDA 510(k) clearance on 2026-04-01, under approval number K253718.

What company makes enHAnce PEEK Bunion System?

enHAnce PEEK Bunion System is manufactured by Nvision Biomedical Technologies, Inc..

What is the FDA product code for enHAnce PEEK Bunion System?

The FDA product code for enHAnce PEEK Bunion System is HRS.

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Related PubMed Literature

PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Other Devices by Nvision Biomedical Technologies, Inc.

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Related Devices (Code: HRS)

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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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