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

Clearance record K193378

CarboClear Lumbar Cage System · CarboFix Orthopedics , Ltd. · decided 2020-03-02 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CarboClear Lumbar Cage SystemShaver – 11 mmCARBOFIX ORTHOPEDICS LTDMAX07290110206451
CarboClear Lumbar Cage SystemSterilization BoxCARBOFIX ORTHOPEDICS LTDMAX07290110206635
CarboClear Lumbar Cage SystemImplant Trial-10x23x10mmCARBOFIX ORTHOPEDICS LTDMAX07290110206857
CarboClear Lumbar Cage SystemT-HandleCARBOFIX ORTHOPEDICS LTDMAX07290110206499
CarboClear Lumbar Cage SystemCage Inserter – Inner Rod M3CARBOFIX ORTHOPEDICS LTDMAX07290110208684
CarboClear Lumbar Cage SystemCubic CageCARBOFIX ORTHOPEDICS LTDMAX07290110206543
CarboClear Lumbar Cage SystemCage Inserter – Inner RodCARBOFIX ORTHOPEDICS LTDMAX07290110206567
CarboClear Lumbar Cage SystemImplant Trial-10x23x14mmCARBOFIX ORTHOPEDICS LTDMAX07290110206871
CarboClear Lumbar Cage SystemSlap Graft HammerCARBOFIX ORTHOPEDICS LTDMAX07290110206574
CarboClear Lumbar Cage SystemCubic CageCARBOFIX ORTHOPEDICS LTDMAX07290110206666
CarboClear Lumbar Cage SystemCubic CageCARBOFIX ORTHOPEDICS LTDMAX07290110206529
CarboClear Lumbar Cage SystemImplant Trial-10x23x12mmCARBOFIX ORTHOPEDICS LTDMAX07290110206864
CarboClear Lumbar Cage SystemShaver – 13 mmCARBOFIX ORTHOPEDICS LTDMAX07290110206475
CarboClear Lumbar Cage SystemCubic CageCARBOFIX ORTHOPEDICS LTDMAX07290110206642
CarboClear Lumbar Cage SystemShaver – 8 mmCARBOFIX ORTHOPEDICS LTDMAX07290110206420
CarboClear Lumbar Cage SystemShaver – 12 mmCARBOFIX ORTHOPEDICS LTDMAX07290110206468
CarboClear Lumbar Cage SystemCubic CageCARBOFIX ORTHOPEDICS LTDMAX07290110206536
CarboClear Lumbar Cage SystemBone FunnelCARBOFIX ORTHOPEDICS LTDMAX07290110206611
CarboClear Lumbar Cage SystemShaver – 10 mmCARBOFIX ORTHOPEDICS LTDMAX07290110206444
CarboClear Lumbar Cage SystemCubic CageCARBOFIX ORTHOPEDICS LTDMAX07290110206659
CarboClear Lumbar Cage SystemImplant Trial-10x27x8mmCARBOFIX ORTHOPEDICS LTDMAX07290110206888
CarboClear Lumbar Cage SystemBone Graft TampCARBOFIX ORTHOPEDICS LTDMAX07290110206628
CarboClear Lumbar Cage SystemImplant Trial-10x23x8mmCARBOFIX ORTHOPEDICS LTDMAX07290110206840
CarboClear Lumbar Cage SystemCubic CageCARBOFIX ORTHOPEDICS LTDMAX07290110206505
CarboClear Lumbar Cage SystemCubic CageCARBOFIX ORTHOPEDICS LTDMAX07290110206512