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

Clearance record K220652

Knee 3 · Brainlab AG · decided 2022-06-03 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Knee Plane Tool-Bone Verification Plate53204Brainlab SEOLO04056481005597
ClearLens Knee Plane Tool53238ABrainlab SEOLO04056481138738
Knee 33.3Brainlab SEOLO04056481143107
Knee Plane Tool - Array53201Brainlab SEOLO04056481005627
Knee Plane Tool - Cb Adapter53202Brainlab SEOLO04056481005610
Adj Cutb - Fem Align Guide53212ABrainlab SEOLO04056481001834
Adj Cutb - Fem Base Small53219ABrainlab SEOLO04056481095130
ClearLens Bone Fixator 2-Pin Right53240ABrainlab SEOLO04056481138752
Adj Cutb - Cut Slot Fem 1.27Mm53221BBrainlab SEOLO04056481140007
Adj Cutb - Fem Ref Array53211ABrainlab SEOLO04056481001841
Adj Cutb - Fem Base53213ABrainlab SEOLO04056481001827
ClearLens ® Pointer Gauge – Knee53237-10Brainlab SEOLO04056481141783
ClearLens Bone Fixator 2-Pin Left53239ABrainlab SEOLO04056481138745
Adj Cutb - Cut Slot Fem 1.19Mm53220BBrainlab SEOLO04056481139995
ClearLens Pointer Handle - Knee53237ABrainlab SEOLO04056481138721
Bl Pointer Knee Straight52782Brainlab SEOLO04056481005771
Gauge Bl Pointer Knee Straight52782-10Brainlab SEOLO04056481002145
Adj Cutb - Cut Slot Fem 1.37Mm53222BBrainlab SEOLO04056481139988
Knee Plane Tool-Bone Verification Plate Partial53205Brainlab SEOLO04056481138912
Adj Cutb - Adj Unit53210BBrainlab SEOLO04056481139513
Knee Plane Tool - Bone Plate53203Brainlab SEOLO04056481005603