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

Clearance record K201926

CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System · CarboFix Orthopedics , Ltd. · decided 2020-08-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CarboClear Pedicle Screw SystemPedicle Screw - Non CannulatedCARBOFIX ORTHOPEDICS LTDNKB07290110207410
CarboClear Pedicle Screw SystemPedicle Screw - Non CannulatedCARBOFIX ORTHOPEDICS LTDNKB07290110207380
CarboClear Pedicle Screw SystemPedicle Screw - Non CannulatedCARBOFIX ORTHOPEDICS LTDNKB07290110207403
CarboClear Pedicle Screw SystemPedicle Screw - Non CannulatedCARBOFIX ORTHOPEDICS LTDNKB07290110207663
CarboClear Pedicle Screw SystemPedicle Screw - Non CannulatedCARBOFIX ORTHOPEDICS LTDNKB07290110207397
CarboClear Pedicle Screw SystemPedicle Screw - Non CannulatedCARBOFIX ORTHOPEDICS LTDNKB07290110207427