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

Clearance record K213768

Bolt Navigation System · Circinus Medical Technology, LLC · decided 2022-12-01 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Bolt Navigation BN002-01-10Circinus Medical Technology LLCOWBB981BN00201103
Bolt Navigation BN001-02Circinus Medical Technology LLCOWBBN981BN001021
Bolt Navigation BN002-02Circinus Medical Technology LLCOWBBN981BN002023
Bolt Navigation BN001-01-01Circinus Medical Technology LLCOWBB981BN0010101