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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 the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2026-04-01 under 510(k) 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. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K253718.

When did enHAnce PEEK Bunion System receive FDA 510(k) clearance?

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

Who is the listed applicant for enHAnce PEEK Bunion System?

The FDA 510(k) record lists Nvision Biomedical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Nvision Biomedical Technologies, Inc. as applicant

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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