Tybr Health - FDA 510(k) Cleared Devices

Tybr Health, develops orthopedic surgical solutions focused on soft tissue healing and mobility preservation. The company is based in Houston, Texas, with an FDA-registered facility in the same location.

Tybr Health has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory activity began in 2025, with its cleared device falling within the orthopedic category. This recent clearance demonstrates active engagement in the medical device market.

The company's cleared device, TYBR Collagen Gel, is designed to optimize post-operative tendon healing by creating a protective biological environment that prevents restrictive scar formation while supporting natural tissue remodeling. The product uses a decellularized extracellular matrix (ECM) approach with visual application guidance to ensure precise surgical placement.

For detailed information on cleared device names, product codes, and clearance dates, explore the full regulatory record.

510(k) submissions have been managed by Bruder Consulting & Venture Group as regulatory consultant.