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

Clearance record K143407

Klassic HD Hip System · Total Joint Othopedics, Inc. · decided 2014-12-23 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
36mm BIOLOX delta Femoral Head, 12/14 taper, +7mm Head Length 3203.36.700TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011597
32mm BIOLOX delta Femoral Head, 12/14 taper, +0mm Head Length 3203.32.000TOTAL JOINT ORTHOPEDICS, INC.LPH MBL00814703011535
36mm BIOLOX delta Femoral Head, 12/14 taper, +0mm Head Length 3203.36.000TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011573
36mm BIOLOX delta Femoral Head, 12/14 taper, -3.5mm Head Length 3203.36.035TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011566
32mm BIOLOX delta Femoral Head, 12/14 taper, -3.5mm Head Length 3203.32.035TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011528
Adapter for BIOLOX OPTION Femoral Head, +0mm head length 3301.00.000TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011634
36mm BIOLOX OPTION Femoral Head, 16/18 taper 3204.36.000TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011610
32mm BIOLOX OPTION Femoral Head, 16/18 taper 3204.32.000TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011603
Adapter for BIOLOX OPTION Femoral Head, +3.5mm head length 3301.00.350TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011641
32mm BIOLOX delta Femoral Head, 12/14 taper, +7mm Head Length 3203.32.700TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011559
Adapter for BIOLOX OPTION Femoral Head, +7mm head length 3301.00.700TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011658
32mm BIOLOX delta Femoral Head, 12/14 taper, +3.5mm Head Length 3203.32.350TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011542
Adapter for BIOLOX OPTION Femoral Head, -3.5mm head length 3301.00.035TOTAL JOINT ORTHOPEDICS, INC.LPH MBL00814703011627
36mm BIOLOX delta Femoral Head, 12/14 taper, +3.5mm Head Length 3203.36.350TOTAL JOINT ORTHOPEDICS, INC.LPH LZO MBL00814703011580