Medical Device Manufacturer · US , Plano , TX

Ulrich Medical USA, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2024
4
Total
4
Cleared
0
Denied

Ulrich Medical USA, Inc. is a medical technology company specializing in orthopedic surgical devices. The company operates with a manufacturing facility in Plano, Texas. Ulrich Medical is known for its "Made in Germany" engineering approach and comprehensive spinal surgery solutions.

The company has received 4 FDA 510(k) clearances from 4 total submissions. All submissions have focused on orthopedic devices, reflecting the company's specialized expertise in spinal fixation and fusion technologies. First clearance in 2024 and latest clearance in 2026 demonstrate active regulatory engagement and recent market activity.

Ulrich Medical's cleared portfolio includes spinal fixation systems, cervical interbody devices, and posterior spinal fusion solutions. The company offers rod-screw systems, vertebral body replacements, interbody cages, and cervical plate systems. These products support anterior and posterior cervical fusion, thoracolumbar fusion, and dynamic stabilization procedures.

Explore the complete list of cleared device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Empirical Technologies as regulatory consultant.

FDA 510(k) Regulatory Record - Ulrich Medical USA, Inc.
4 devices
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