Cleared Special

BioBrace? Reinforced Implant

K241906 · Conmed Corporation · Orthopedic

Jul 2024

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K241906 is an FDA 510(k) clearance for the BioBrace? Reinforced Implant, a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWW), submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on July 29, 2024, 28 days after receiving the submission on July 1, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K241906 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2024
Decision Date	July 29, 2024
Days to Decision	28 days
Submission Type	Special
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.