FDA-Device2018-06-13Class II
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
VGI Medical, LLC
Hazard
IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
Sold states
Distributed to MI, FL, and NY.
Affected count
6 units
Manufactured in
10401 Belcher Rd S, N/A, Seminole, FL, United States
Products
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2100-2018Don't want to check this manually?
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