FDA-Device2020-11-11Class II
Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Hazard
System does not include a drill guide.
Sold states
Distributed to one distributor in Michigan.
Affected count
76 units
Manufactured in
375 River Park Cir, N/A, Marquette, MI, United States
Products
Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0322-2021Don't want to check this manually?
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