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 a medical device manufactured by Science & Bio Materials (S.B.M.) Sas. It received FDA 510(k) clearance on 2023-07-26 under approval 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. It is manufactured by Science & Bio Materials (S.B.M.) Sas. The 510(k) number is K231787.

When was ecoFIX® approved by the FDA?

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

What company makes ecoFIX®?

ecoFIX® is manufactured by Science & Bio Materials (S.B.M.) Sas.

What is the FDA product code for ecoFIX®?

The FDA product code for ecoFIX® is MAI.

Other Devices by Science & Bio Materials (S.B.M.) Sas

K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop

Related Devices (Code: MAI)

K161174Nanova Interference ScrewNanova Biomaterials, Inc. K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARL K151342Arthrex SwiveLock AnchorsArthrex, Inc. K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL K171592CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation

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.