Medical Device Manufacturer · US , Washington , DC

Spineworks, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2005
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
K133340 · MAX
Orthopedic · 163d
Cleared Sep 08, 2011
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
K111166 · MAX
Orthopedic · 135d
Cleared Jul 23, 2008
FIXXSURE CROSS LINK
K081331 · MNH
Orthopedic · 72d
Cleared Feb 18, 2005
STANSION MATRIX
K042600 · MQP
Orthopedic · 148d
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