Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Type Device Class Implantable

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MALIBU DLTA SCREW 7.5 DIA X 60 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7560
Not in Commercial Distribution

  • 10889981003531 ()

  • 7.5 DIA X 60 mm
15-7560

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 55 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7555
In Commercial Distribution

  • 10889981003524 ()

  • 7.5 DIA X 55 mm
15-7555

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 50 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7550
In Commercial Distribution

  • 10889981003517 ()

  • 7.5 DIA X 50 mm
15-7550

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 40 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7540
In Commercial Distribution

  • 10889981003494 ()

  • 7.5 DIA X 40 mm
15-7540

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 35 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7535
In Commercial Distribution

  • 10889981003487 ()

  • 7.5 DIA X 35 mm
15-7535

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 30 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7530
Not in Commercial Distribution

  • 10889981003470 ()

  • 7.5 DIA X 30 mm
15-7530

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 70 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7070
Not in Commercial Distribution

  • 10889981003463 ()

  • 7.0 DIA X 70 mm
15-7070

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 65 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7065
Not in Commercial Distribution

  • 10889981003456 ()

  • 7.0 DIA X 65 mm
15-7065

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 60 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7060
Not in Commercial Distribution

  • 10889981003449 ()

  • 7.0 DIA X 60 mm
15-7060

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 55 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7055
Not in Commercial Distribution

  • 10889981003432 ()

  • 7.0 DIA X 55 mm
15-7055

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 50 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7050
Not in Commercial Distribution

  • 10889981003425 ()

  • 7.0 DIA X 50 mm
15-7050

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 45 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7045
Not in Commercial Distribution

  • 10889981003418 ()

  • 7.0 DIA X 45 mm
15-7045

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 40 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7040
Not in Commercial Distribution

  • 10889981003401 ()

  • 7.0 DIA X 40 mm
15-7040

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 35 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7035
Not in Commercial Distribution

  • 10889981003395 ()

  • 7.0 DIA X 35 mm
15-7035

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 30 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7030
Not in Commercial Distribution

  • 10889981003388 ()

  • 7.0 DIA X 30 mm
15-7030

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.5 DIA X 70 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6570
Not in Commercial Distribution

  • 10889981003371 ()

  • 6.5 DIA X 70 mm
15-6570

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.5 DIA X 65 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6565
Not in Commercial Distribution

  • 10889981003364 ()

  • 6.5 DIA X 65 mm
15-6565

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.5 DIA X 60 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6560
Not in Commercial Distribution

  • 10889981003357 ()

  • 6.5 DIA X 60 mm
15-6560

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.5 DIA X 55 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6555
In Commercial Distribution

  • 10889981003340 ()

  • 6.5 DIA X 55 mm
15-6555

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.5 DIA X 50 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6550
In Commercial Distribution

  • 10889981003333 ()

  • 6.5 DIA X 50 mm
15-6550

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.5 DIA X 45 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6545
In Commercial Distribution

  • 10889981003326 ()

  • 6.5 DIA X 45 mm
15-6545

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.5 DIA X 35 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6535
In Commercial Distribution

  • 10889981003302 ()

  • 6.5 DIA X 35 mm
15-6535

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.0 DIA X 55 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6055
Not in Commercial Distribution

  • 10889981003289 ()

  • 6.0 DIA X 55 mm
15-6055

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.0 DIA X 45 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6045
Not in Commercial Distribution

  • 10889981003265 ()

  • 6.0 DIA X 45 mm
15-6045

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.0 DIA X 40 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6040
Not in Commercial Distribution

  • 10889981003258 ()

  • 6.0 DIA X 40 mm
15-6040

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.0 DIA X 35 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6035
Not in Commercial Distribution

  • 10889981003241 ()

  • 6.0 DIA X 35 mm
15-6035

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.0 DIA X 30 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6030
Not in Commercial Distribution

  • 10889981003234 ()

  • 6.0 DIA X 30 mm
15-6030

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.0 DIA X 25 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6025
Not in Commercial Distribution

  • 10889981003227 ()

  • 6.0 DIA X 25 mm
15-6025

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 5.5 DIA X 50 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5550
In Commercial Distribution

  • 10889981003203 ()

  • 5.5 DIA X 50 mm
15-5550

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 5.5 DIA X 45 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5545
In Commercial Distribution

  • 10889981003197 ()

  • 5.5 DIA X 45 mm
15-5545

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 5.5 DIA X 40 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5540
In Commercial Distribution

  • 10889981003180 ()

  • 5.5 DIA X 40 mm
15-5540

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 5.5 DIA X 35 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5535
In Commercial Distribution

  • 10889981003173 ()

  • 5.5 DIA X 35 mm
15-5535

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 5.5 DIA X 30 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5530
In Commercial Distribution

  • 10889981003166 ()

  • 5.5 DIA X 30 mm
15-5530

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 5.0 DIA X 50 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5050
Not in Commercial Distribution

  • 10889981003142 ()

  • 5.0 DIA X 50 mm
15-5050

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 4.5 DIA X 25 mm
SEASPINE ORTHOPEDICS CORPORATION
15-4525
In Commercial Distribution

  • 10889981003043 ()

  • 4.5 DIA X 25 mm
15-4525

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
13-8560
Not in Commercial Distribution

  • 10889981002930 ()

  • 8.5 x 60mm
13-8560

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
13-8540
Not in Commercial Distribution

  • 10889981002893 ()

  • 8.5 x 40mm
13-8540

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
13-8530
Not in Commercial Distribution

  • 10889981002879 ()

  • 8.5 x 30mm
13-8530

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
13-8510
In Commercial Distribution

  • 10889981002862 ()

  • 8.5 x 110mm
13-8510

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 100mm
SEASPINE ORTHOPEDICS CORPORATION
13-8500
In Commercial Distribution

  • 10889981002848 ()

  • 8.5 x 100mm
13-8500

  • Bone-screw internal spinal fixation system, non-sterile
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