Cleared Traditional

VersaWrap

K240817 · Alafair Biosciences, Inc. · Orthopedic

Jun 2024

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K240817 is an FDA 510(k) clearance for the VersaWrap, a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWW), submitted by Alafair Biosciences, Inc. (Austin, US). The FDA issued a Cleared decision on June 14, 2024, 81 days after receiving the submission on March 25, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K240817 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2024
Decision Date	June 14, 2024
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWW — Mesh, Surgical, Absorbable, 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 During Tendon Repair Procedures.