Cleared Special

VersaWrap Tendon Protector

K200311 · Alafair Biosciences, Inc. · General & Plastic Surgery
Mar 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K200311 is an FDA 510(k) clearance for the VersaWrap Tendon Protector, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Alafair Biosciences, Inc. (Austin, US). The FDA issued a Cleared decision on March 6, 2020, 29 days after receiving the submission on February 6, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K200311 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2020
Decision Date March 06, 2020
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTM — Mesh, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300