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FDA 510(k)

Bioabsorbable Anchor

K-Number: K213958 · 2022-04-08

ApplicantEmbody, Inc.
Decision Date2022-04-08
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Bioabsorbable Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Embody, Inc.. It received FDA 510(k) clearance on 2022-04-08 under 510(k) 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. The listed applicant is Embody, Inc.. The 510(k) number is K213958.

When did Bioabsorbable Anchor receive FDA 510(k) clearance?

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

Who is the listed applicant for Bioabsorbable Anchor?

The FDA 510(k) record lists Embody, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bioabsorbable Anchor?

The FDA product code for Bioabsorbable Anchor is MAI.

Other records listing Embody, Inc. 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.

K252647Tapestry Biointegrative ImplantK223822ACTIVBRAID™K220867Tapestry Biointegrative ImplantK212306Tapestry Biointegrative ImplantK201572TAPESTRY Biointegrative Implant

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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed 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.

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