FDA-Device2025-09-10Class II
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
PREMIA SPINE LTD
Hazard
Potential for missing pins at tip of inserter.
Sold states
US Nationwide distribution in the state of Connecticut.
Affected count
30 units
Manufactured in
Giborey Israel 7, Ramat Poleg, Netanya, N/A, Israel
Products
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2516-2025Don't want to check this manually?
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