Cleared Traditional

Tapestry Biointegrative Implant

K220867 · Embody, Inc. · Orthopedic

May 2022

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K220867 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 May 23, 2022, 59 days after receiving the submission on March 25, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K220867 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2022
Decision Date	May 23, 2022
Days to Decision	59 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.