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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K201189

Stealthstation S8 Spine Software v1.3.0 · Medtronic Navigation, Inc. · decided 2020-05-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
StealthStation S8 Spine9735919MEDTRONIC NAVIGATION, INC.OLO00763000377939
StealthStation S8 Spine9735740MEDTRONIC NAVIGATION, INC.OLO00763000378240
Medtronic Navigation9735740MEDTRONIC NAVIGATION, INC.OLO00763000457204
StealthAiR™ Spine9736350MEDTRONIC NAVIGATION, INC.OLO00763000385637
StealthAiR™ Spine9736350MEDTRONIC NAVIGATION, INC.OLO00763000416805