FDA 510(k)

Bioabsorbable Anchor

K-Number: K213958 · 2022-04-08

Decision Date2022-04-08

Product CodeMAI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Bioabsorbable Anchor is a medical device manufactured by Embody, Inc.. It received FDA 510(k) clearance on 2022-04-08 under approval number K213958. 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 Bioabsorbable Anchor?

Bioabsorbable Anchor is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Embody, Inc.. The 510(k) number is K213958.

When was Bioabsorbable Anchor approved by the FDA?

Bioabsorbable Anchor received FDA 510(k) clearance on 2022-04-08, under approval number K213958.

What company makes Bioabsorbable Anchor?

Bioabsorbable Anchor is manufactured by Embody, Inc..

What is the FDA product code for Bioabsorbable Anchor?

The FDA product code for Bioabsorbable Anchor is MAI.

Other Devices by Embody, Inc.

K201572TAPESTRY Biointegrative Implant K212306Tapestry Biointegrative Implant K220867Tapestry Biointegrative Implant K223822ACTIVBRAID K252647Tapestry Biointegrative Implant

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.