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FDA 510(k)

SINEFIX

K-Number: K220966 · 2023-03-08

ApplicantBAAT Medical Products B.V.
Decision Date2023-03-08
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SINEFIX is a medical device manufactured by BAAT Medical Products B.V.. It received FDA 510(k) clearance on 2023-03-08 under approval number K220966. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINEFIX?

SINEFIX is a medical device that received FDA 510(k) clearance on 2023-03-08. It is manufactured by BAAT Medical Products B.V.. The 510(k) number is K220966.

When was SINEFIX approved by the FDA?

SINEFIX received FDA 510(k) clearance on 2023-03-08, under approval number K220966.

What company makes SINEFIX?

SINEFIX is manufactured by BAAT Medical Products B.V..

What is the FDA product code for SINEFIX?

The FDA product code for SINEFIX is MBI.

Other Devices by BAAT Medical Products B.V.

K201830ANSER Clavicle Pin K211474Kleiner KG2 System K254176SINEFIX K251961SDS Growing Rod

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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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