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FDA 510(k)

ecoFIX®

K-Number: K231787 · 2023-07-26

ApplicantScience & Bio Materials (S.B.M.) Sas
Decision Date2023-07-26
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ecoFIX® is the device name listed in this FDA 510(k) record. The listed applicant is Science & Bio Materials (S.B.M.) Sas. It received FDA 510(k) clearance on 2023-07-26 under 510(k) number K231787. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ecoFIX®?

ecoFIX® is a medical device that received FDA 510(k) clearance on 2023-07-26. The listed applicant is Science & Bio Materials (S.B.M.) Sas. The 510(k) number is K231787.

When did ecoFIX® receive FDA 510(k) clearance?

ecoFIX® received FDA 510(k) clearance on 2023-07-26, under 510(k) number K231787.

Who is the listed applicant for ecoFIX®?

The FDA 510(k) record lists Science & Bio Materials (S.B.M.) Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ecoFIX®?

The FDA product code for ecoFIX® is MAI.

Other records listing Science & Bio Materials (S.B.M.) 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.

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Related Devices (Code: MAI)

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

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