Medical Device Manufacturer · US , Washington , DC

Spineworks, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2005

Recent clearances: SPINEWORKS ANTERIOR LUMBAR DEVICE, A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.), FIXXSURE CROSS LINK

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Apr 11, 2014

SPINEWORKS ANTERIOR LUMBAR DEVICE

Orthopedic · 163d

Cleared Sep 08, 2011

A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)

Orthopedic · 135d

Cleared Jul 23, 2008

FIXXSURE CROSS LINK

Orthopedic · 72d

Cleared Feb 18, 2005

STANSION MATRIX

Orthopedic · 148d