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

Clearance record K233944

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments · CarboFix Orthopedics , Ltd. · decided 2024-01-10 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedCARBOFIX ORTHOPEDICS LTDNKB OLO07290110209803
CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedCARBOFIX ORTHOPEDICS LTDNKB OLO07290110209827
CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedCARBOFIX ORTHOPEDICS LTDNKB OLO07290110209797
CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedCARBOFIX ORTHOPEDICS LTDNKB OLO07290110209834
CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedCARBOFIX ORTHOPEDICS LTDNKB OLO07290110209780