Spectrum Spine, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Spectrum Spine, LLC - FDA 510(k) Cleared Devices
Recent clearances: Expandable Titanium PLIF/TLIF System, Spectrum Spine Expandable Cages (SSEC)
4
Total
4
Cleared
0
Denied
Spectrum Spine, LLC has 4 FDA 510(k) cleared medical devices. Based in Colorado Springs, US.
Last cleared in 2021. Active since 2013. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Spectrum Spine, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Empirical Testing Corp as regulatory consultant.
FDA 510(k) Regulatory Record - Spectrum Spine, LLC
4 devices
Cleared
Apr 29, 2021
Expandable Titanium PLIF/TLIF System
Orthopedic
374d
Cleared
Mar 07, 2019
Spectrum Spine Expandable Cages (SSEC)
Orthopedic
478d
Cleared
Oct 28, 2013
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
Orthopedic
110d
Cleared
Feb 07, 2013
SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
Orthopedic
146d