Medical Device Manufacturer · US , Elyria , OH

Surgical Theater, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2013

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Surgical Theater, LLC Radiology ✕

4 devices

1-4 of 4

Cleared Feb 12, 2018

SuRgical Planner (SRP)

Radiology · 333d

Cleared Jun 28, 2016

Surgical Navigation Advanced Platform (SNAP)

Radiology · 119d

Cleared Jun 27, 2014

SURGICAL NAVIGATION ADVANCED PLATFORM

Radiology · 87d

Cleared Feb 08, 2013

SURGERY REHEARSAL PLATFORM

Radiology · 133d