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

Clearance record K240846

CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement · CarboFix Orthopedics , Ltd. · decided 2024-04-25 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw CARBOFIX ORTHOPEDICS LTDNKB PML07290117356685
CarboClear Hybrid Pedicle Screw SystemPedicle Screw - Dual ThreadCARBOFIX ORTHOPEDICS LTDNKB PML07290117356111
CarboClear X Pedicle Screw SystemPedicle Screw - Dual ThreadCARBOFIX ORTHOPEDICS LTDNKB OLO PML07290117355268
CarboClear X Pedicle Screw SystemPedicle Screw - Dual ThreadCARBOFIX ORTHOPEDICS LTDNKB OLO PML07290117355220
CarboClear Hybrid Pedicle Screw SystemMIS Pedicle Screw CARBOFIX ORTHOPEDICS LTDNKB PML07290117354049
CarboClear Hybrid Pedicle Screw SystemMIS Pedicle Screw CARBOFIX ORTHOPEDICS LTDNKB PML07290117353936
CarboClear Hybrid Pedicle Screw SystemDistractor-Compressor CARBOFIX ORTHOPEDICS LTDNKB PML07290117358429
CarboClear Modular Hybrid Pedicle Screw SystemPedicle ScrewCARBOFIX ORTHOPEDICS LTDNKB PML07290117357729
CarboClear Hybrid Pedicle Screw SystemMIS Pedicle Screw CARBOFIX ORTHOPEDICS LTDNKB PML07290117354148
CarboClear Hybrid Pedicle Screw SystemPedicle Screw - Dual ThreadCARBOFIX ORTHOPEDICS LTDNKB PML07290117356050
CarboClear Hybrid Pedicle Screw SystemPedicle Screw - Dual ThreadCARBOFIX ORTHOPEDICS LTDNKB PML07290117355947
CarboClear X Pedicle Screw SystemPedicle Screw - Dual ThreadCARBOFIX ORTHOPEDICS LTDNKB OLO PML07290117355145
CarboClear X Pedicle Screw SystemPedicle Screw - Dual ThreadCARBOFIX ORTHOPEDICS LTDNKB OLO PML07290117355084
CarboClear Hybrid Pedicle Screw SystemMIS Pedicle Screw CARBOFIX ORTHOPEDICS LTDNKB PML07290117353868
CarboClear Hybrid Pedicle Screw SystemDistractor-Compressor CARBOFIX ORTHOPEDICS LTDNKB PML07290117353790
CarboClear Hybrid Pedicle Screw SystemPedicle Screw - FenestratedCARBOFIX ORTHOPEDICS LTDNKB PML07290117352625
CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw CARBOFIX ORTHOPEDICS LTDNKB PML07290117356838
CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw CARBOFIX ORTHOPEDICS LTDNKB PML07290117356456
CarboClear Hybrid Pedicle Screw SystemPedicle Screw - Dual ThreadCARBOFIX ORTHOPEDICS LTDNKB PML07290117356104
CarboClear Hybrid Pedicle Screw SystemMIS Pedicle Screw CARBOFIX ORTHOPEDICS LTDNKB PML07290117354209
CarboClear Hybrid Pedicle Screw SystemMIS Pedicle Screw CARBOFIX ORTHOPEDICS LTDNKB PML07290117353875
CarboClear Hybrid Pedicle Screw SystemMIS Fenestrated Screw CannulaCARBOFIX ORTHOPEDICS LTDNKB PML07290117353608
CarboClear Hybrid Pedicle Screw SystemPedicle Screw - FenestratedCARBOFIX ORTHOPEDICS LTDNKB PML07290117352618
CarboClear Hybrid Pedicle Screw SystemMIS Dual Thread Pedicle Screw CARBOFIX ORTHOPEDICS LTDNKB PML07290117356715
CarboClear Hybrid Pedicle Screw SystemMIS Pedicle Screw CARBOFIX ORTHOPEDICS LTDNKB PML07290117353905