Cleared Traditional

FlexBand; FlexPatch; FlexBand Plus

K230316 · International Life Sciences · Orthopedic

May 2023

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K230316 is an FDA 510(k) clearance for the FlexBand; FlexPatch; FlexBand Plus, a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWW), submitted by International Life Sciences (Marietta, US). The FDA issued a Cleared decision on May 26, 2023, 109 days after receiving the submission on February 6, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K230316 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2023
Decision Date	May 26, 2023
Days to Decision	109 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.