K252647

Tapestry Biointegrative Implant

510(k) number
K252647
Device name
Tapestry Biointegrative Implant
Applicant
Embody, Inc. VA · US
Product code
OWY — Mesh, Surgical, Collagen, Orthopaedics, Reinforcemen
Decision date
2025-09-19
Date received
2025-08-21
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
General, Plastic Surgery
510(k) Summary (official FDA PDF): K252647.pdf
Official FDA record: K252647
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.