Cleared Traditional

TYBR Collagen Gel

K250109 · Tybr Health · Orthopedic

Jun 2025

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K250109 is an FDA 510(k) clearance for the TYBR Collagen Gel, a Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWY), submitted by Tybr Health (Houston, US). The FDA issued a Cleared decision on June 6, 2025, 141 days after receiving the submission on January 16, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K250109 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 2025
Decision Date	June 06, 2025
Days to Decision	141 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.