Tapestry Biointegrative Implant— 510(k) K212306

Substantially Equivalent

Embody, Inc.

FDA 510(k) clearance K212306 for Tapestry Biointegrative Implant, Substantially Equivalent on 2021-11-02. Applicant: Embody, Inc.. Device class: 2.

Clearance details

Applicant: Embody, Inc.
Product code: Code OWY
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2021-07-23
Decision date: 2021-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norfolk, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWY

K251690 — Arthrex SpeedFLEX Implant2025-09-30
K252647 — Tapestry Biointegrative Implant2025-09-19
K250109 — TYBR Collagen Gel2025-06-06
K243843 — Tendon Protect (50242)2025-06-04
K242631 — REGENETEN Bioinductive Implant2024-11-26

More clearances from Embody, Inc.

K223822 — ACTIVBRAID2023-06-02
K220867 — Tapestry Biointegrative Implant2022-05-23
K213958 — Bioabsorbable Anchor2022-04-08
K201572 — TAPESTRY Biointegrative Implant2020-10-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.