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FDA 510(k)

Tapestry Biointegrative Implant

K-Number: K212306 · 2021-11-02

ApplicantEmbody, Inc.
Decision Date2021-11-02
Product CodeOWY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tapestry Biointegrative Implant is a medical device manufactured by Embody, Inc.. It received FDA 510(k) clearance on 2021-11-02 under approval number K212306. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tapestry Biointegrative Implant?

Tapestry Biointegrative Implant is a medical device that received FDA 510(k) clearance on 2021-11-02. It is manufactured by Embody, Inc.. The 510(k) number is K212306.

When was Tapestry Biointegrative Implant approved by the FDA?

Tapestry Biointegrative Implant received FDA 510(k) clearance on 2021-11-02, under approval number K212306.

What company makes Tapestry Biointegrative Implant?

Tapestry Biointegrative Implant is manufactured by Embody, Inc..

What is the FDA product code for Tapestry Biointegrative Implant?

The FDA product code for Tapestry Biointegrative Implant is OWY.

Related Clinical Trials

Other Devices by Embody, Inc.

Related Devices (Code: OWY)

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.