Medical Device Manufacturer · US , Miami Beach , FL

Sintea Plastek, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2011

Recent clearances: SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS, DSC/ALF SPINAL SYSTEM

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sintea Plastek, LLC Orthopedic ✕

2 devices

1-2 of 2

Cleared Apr 25, 2012

SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS

Orthopedic · 231d

Cleared Jul 21, 2011

DSC/ALF SPINAL SYSTEM

Orthopedic · 380d