FDA 510(k)

GENTAFIX® (1, 3, 3MV)

K-Number: K242216 · 2024-12-18

Decision Date2024-12-18

Product CodeMBB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

GENTAFIX® (1, 3, 3MV) is the device name listed in this FDA 510(k) record. The listed applicant is Teknimed Sas. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K242216. The device is classified under product code MBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTAFIX® (1, 3, 3MV)?

GENTAFIX® (1, 3, 3MV) is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Teknimed Sas. The 510(k) number is K242216.

When did GENTAFIX® (1, 3, 3MV) receive FDA 510(k) clearance?

GENTAFIX® (1, 3, 3MV) received FDA 510(k) clearance on 2024-12-18, under 510(k) number K242216.

Who is the listed applicant for GENTAFIX® (1, 3, 3MV)?

The FDA 510(k) record lists Teknimed Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENTAFIX® (1, 3, 3MV)?

The FDA product code for GENTAFIX® (1, 3, 3MV) is MBB.

Other records listing Teknimed Sas as applicant

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.

K161114HIGH V+

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Official Source

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