Cleared Traditional

K201572 - TAPESTRY Biointegrative Implant
(FDA 510(k) Clearance)

K201572 · Embody, Inc. · Orthopedic

Oct 2020

Decision

130d

Days

Class 2

Risk

K201572 is an FDA 510(k) clearance for the TAPESTRY Biointegrative Implant, a Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWY), submitted by Embody, Inc. (Norfolk, US). The FDA issued a Cleared decision on October 19, 2020, 130 days after receiving the submission on June 11, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K201572 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2020
Decision Date	October 19, 2020
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWY — Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair.