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

Clearance record K201251

CarboClear Navigated Instruments · CarboFix Orthopedics , Ltd. · decided 2020-08-05 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CarboClear Pedicle Screw SystemNavigated Tap 7.5mmCARBOFIX ORTHOPEDICS LTDNKB OLO07290110208455
CarboClear Pedicle Screw SystemNavigated ScrewdriverCARBOFIX ORTHOPEDICS LTDNKB OLO07290110208417
CarboClear Pedicle Screw SystemNavigated Tap 5.5mmCARBOFIX ORTHOPEDICS LTDNKB OLO07290110208493
CarboClear Pedicle Screw SystemNavigated Tap 4.5mmCARBOFIX ORTHOPEDICS LTDNKB OLO07290110208516
CarboClear Pedicle Screw SystemNavigated Tap 6.0mmCARBOFIX ORTHOPEDICS LTDNKB OLO07290110208486
CarboClear Pedicle Screw SystemNavigated Tap 6.5mmCARBOFIX ORTHOPEDICS LTDNKB OLO07290110208479
CarboClear Pedicle Screw SystemNavigated Probe - Pointed, StraightCARBOFIX ORTHOPEDICS LTDNKB OLO07290110208448
CarboClear Pedicle Screw SystemNavigated Probe - Blunt, StraightCARBOFIX ORTHOPEDICS LTDNKB OLO07290110208400
CarboClear Pedicle Screw SystemNavigated Tap 7.0mmCARBOFIX ORTHOPEDICS LTDNKB OLO07290110208462
CarboClear Pedicle Screw SystemNavigated Tap 5.0mmCARBOFIX ORTHOPEDICS LTDNKB OLO07290110208509