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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 the device name listed in this FDA 510(k) record. The listed applicant is Fixier S.A. DE C.V.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) 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. The listed applicant is Fixier S.A. DE C.V.. The 510(k) number is K201510.

When did Traufix osteosynthesis, osteotomy, and arthrodesis devices receive FDA 510(k) clearance?

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

Who is the listed applicant for Traufix osteosynthesis, osteotomy, and arthrodesis devices?

The FDA 510(k) record lists Fixier S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

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.

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.

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Official Source

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