Medical Device Manufacturer · US , Round Rock , TX

Medicrea International - FDA 510(k) Cleared Devices

17 submissions · 16 cleared · Since 2011

Recent clearances: Infinity™ OCT System and PASS OCT Spinal System, CD Horizon™ Spinal System and PASS LP™ Spinal System, UNiD Spine Analyzer

View 17 510(k) Devices ↓

17

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Medicrea International Radiology ✕

2 devices

1-2 of 2

Cleared Feb 08, 2018

UNiD Spine Analyzer

Radiology · 27d

Cleared May 24, 2017

UNiD Spine Analyzer

Radiology · 125d