TAPESTRY Biointegrative Implant
K-Number: K201572 · 2020-10-19
ApplicantEmbody, Inc.
Decision Date2020-10-19
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 2020-10-19 under approval number K201572. 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 2020-10-19. It is manufactured by Embody, Inc.. The 510(k) number is K201572.
When was TAPESTRY Biointegrative Implant approved by the FDA?
TAPESTRY Biointegrative Implant received FDA 510(k) clearance on 2020-10-19, under approval number K201572.
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.
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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.