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

Clearance record K211188

xvision Spine system (XVS) · Augmedics, Ltd. · decided 2021-07-19 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Perc Insertion CapAMCH07320AUGMEDICS LTDSBF07290113780866
Perc Slap HammerAMCH07370AUGMEDICS LTDSBF07290113780873
Perc Pin 125mm 5 units PackageAMCH07012AUGMEDICS LTDSBF17290113780931
Perc Mallet 250 gr. AMCH07700AUGMEDICS LTDSBF07290113780880
Perc Pin 150mm 5 units PackageAMCH07015AUGMEDICS LTDSBF17290113780924
Augmedics WS-Cart assemblyACC00401AUGMEDICS LTDSBF07290113781061
Perc Schanz Screw Adaptor ShortAMCH07500AUGMEDICS LTDSBF07290113780897
8” Tablet DockingACC00302AUGMEDICS LTDOLO07290113780729
Perc Pin 100mm 5 units PackageAMCH07010AUGMEDICS LTDSBF17290113780948
Rotating Marker Adaptor AMCH00039 AUGMEDICS LTDSBF07290113780965
XVS STERILE COMPONENTS KITASP00050AUGMEDICS LTDSBF07290113780989
8” Tablet ACC00310AUGMEDICS LTDOLO07290113780712
Perc Pin AdaptorAMCH07200AUGMEDICS LTDSBF07290113780910
Schanz Screw Adaptor LongAMCH07550AUGMEDICS LTDSBF07290113780903
Perc Pin TrayAMCH07100AUGMEDICS LTDSBF07290113780859
XVS MARKERS WITH XLINK KITASP00047AUGMEDICS LTDSBF17290113780979
XVISION Instrument TrayASP00044AUGMEDICS LTDSBF07290113780958