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FDA 510(k)

Traufix osteosynthesis, osteotomy, and arthrodesis devices

K-Number: K201510 · 2022-02-18

ApplicantFixier S.A. DE C.V.
Decision Date2022-02-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Traufix osteosynthesis, osteotomy, and arthrodesis devices is a medical device manufactured by Fixier S.A. DE C.V.. It received FDA 510(k) clearance on 2022-02-18 under approval number K201510. 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 Traufix osteosynthesis, osteotomy, and arthrodesis devices?

Traufix osteosynthesis, osteotomy, and arthrodesis devices is a medical device that received FDA 510(k) clearance on 2022-02-18. It is manufactured by Fixier S.A. DE C.V.. The 510(k) number is K201510.

When was Traufix osteosynthesis, osteotomy, and arthrodesis devices approved by the FDA?

Traufix osteosynthesis, osteotomy, and arthrodesis devices received FDA 510(k) clearance on 2022-02-18, under approval number K201510.

What company makes Traufix osteosynthesis, osteotomy, and arthrodesis devices?

Traufix osteosynthesis, osteotomy, and arthrodesis devices is manufactured by Fixier S.A. DE C.V..

What is the FDA product code for Traufix osteosynthesis, osteotomy, and arthrodesis devices?

The FDA product code for Traufix osteosynthesis, osteotomy, and arthrodesis devices is 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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