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FDA 510(k)

Tapestry Biointegrative Implant

K-Number: K252647 · 2025-09-19

ApplicantEmbody, Inc.
Decision Date2025-09-19
Product CodeOWY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tapestry Biointegrative Implant is the device name listed in this FDA 510(k) record. The listed applicant is Embody, Inc.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K252647. 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 2025-09-19. The listed applicant is Embody, Inc.. The 510(k) number is K252647.

When did Tapestry Biointegrative Implant receive FDA 510(k) clearance?

Tapestry Biointegrative Implant received FDA 510(k) clearance on 2025-09-19, under 510(k) number K252647.

Who is the listed applicant for Tapestry Biointegrative Implant?

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 Tapestry Biointegrative Implant?

The FDA product code for Tapestry Biointegrative Implant is OWY.

Related Clinical Trials

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.

NCT05735119Embody Post-Market Clinical Follow-Up StudyACTIVE_NOT_RECRUITING

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.

K223822ACTIVBRAID™K220867Tapestry Biointegrative ImplantK213958Bioabsorbable AnchorK212306Tapestry Biointegrative ImplantK201572TAPESTRY Biointegrative Implant

Related Devices (Code: OWY)

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.

K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.K250109TYBR Collagen GelTybr HealthK243843Tendon Protect (50242)Kerecis LimitedK242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.K220867Tapestry Biointegrative ImplantEmbody, Inc.

Official Source

View on FDA Database →

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

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