Medical Device Manufacturer · US , Mayfield Village , OH

Surgical Theater, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2020

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Surgical Theater, Inc. Orthopedic ✕

3 devices

1-3 of 3

Cleared Sep 29, 2025

SpineAR SNAP (SyncAR Spine)

Orthopedic · 90d

Cleared Dec 24, 2024

SpineAR SNAP (SyncAR Spine)

Orthopedic · 29d

Cleared Sep 29, 2022

Orthopedic · 373d