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FDA 510(k)

GENTAFIX® (1, 3, 3MV)

K-Number: K242216 · 2024-12-18

ApplicantTeknimed Sas
Decision Date2024-12-18
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENTAFIX® (1, 3, 3MV) is a medical device manufactured by Teknimed Sas. It received FDA 510(k) clearance on 2024-12-18 under approval 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. It is manufactured by Teknimed Sas. The 510(k) number is K242216.

When was GENTAFIX® (1, 3, 3MV) approved by the FDA?

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

What company makes GENTAFIX® (1, 3, 3MV)?

GENTAFIX® (1, 3, 3MV) is manufactured by Teknimed Sas.

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

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

Other Devices by Teknimed Sas

K161114HIGH V+

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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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