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 Device Size Type Device Class Implantable

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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 40 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6540
In Commercial Distribution

  • 10889981003319 ()

  • 6.5 DIA X 40 mm
15-6540

  • 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 6.5 DIA X 30 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6530
In Commercial Distribution

  • 10889981003296 ()

  • 6.5 DIA X 30 mm
15-6530

  • 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 50 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6050
Not in Commercial Distribution

  • 10889981003272 ()

  • 6.0 DIA X 50 mm
15-6050

  • 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 55 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5555
Not in Commercial Distribution

  • 10889981003210 ()

  • 5.5 DIA X 55 mm
15-5555

  • 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 5.5 DIA X 25 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5525
In Commercial Distribution

  • 10889981003159 ()

  • 5.5 DIA X 25 mm
15-5525

  • 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 5.0 DIA X 45 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5045
Not in Commercial Distribution

  • 10889981003135 ()

  • 5.0 DIA X 45 mm
15-5045

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 5.0 DIA X 40 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5040
In Commercial Distribution

  • 10889981003128 ()

  • 5.0 DIA X 40 mm
15-5040

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 5.0 DIA X 35 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5035
In Commercial Distribution

  • 10889981003111 ()

  • 5.0 DIA X 35 mm
15-5035

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 5.0 DIA X 30 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5030
In Commercial Distribution

  • 10889981003104 ()

  • 5.0 DIA X 30 mm
15-5030

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 5.0 DIA X 25 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5025
Not in Commercial Distribution

  • 10889981003098 ()

  • 5.0 DIA X 25 mm
15-5025

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 4.5 DIA X 45 mm
SEASPINE ORTHOPEDICS CORPORATION
15-4545
Not in Commercial Distribution

  • 10889981003081 ()

  • 4.5 DIA X 45 mm
15-4545

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 4.5 DIA X 40 mm
SEASPINE ORTHOPEDICS CORPORATION
15-4540
In Commercial Distribution

  • 10889981003074 ()

  • 4.5 DIA X 40 mm
15-4540

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 4.5 DIA X 35 mm
SEASPINE ORTHOPEDICS CORPORATION
15-4535
In Commercial Distribution

  • 10889981003067 ()

  • 4.5 DIA X 35 mm
15-4535

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 4.5 DIA X 30 mm
SEASPINE ORTHOPEDICS CORPORATION
15-4530
In Commercial Distribution

  • 10889981003050 ()

  • 4.5 DIA X 30 mm
15-4530

  • 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 DLTA SCREW 4.5 DIA X 20 mm
SEASPINE ORTHOPEDICS CORPORATION
15-4520
Not in Commercial Distribution

  • 10889981003036 ()

  • 4.5 DIA X 20 mm
15-4520

  • Bone-screw internal spinal fixation system, non-sterile
Cap, LP
SEASPINE ORTHOPEDICS CORPORATION
14-0020
In Commercial Distribution

  • 10889981003029 ()

  • LP
14-0020

  • Bone-screw internal spinal fixation system, non-sterile
SetScrew, LP
SEASPINE ORTHOPEDICS CORPORATION
14-0010
In Commercial Distribution

  • 10889981003012 ()

  • LP
14-0010

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 95mm
SEASPINE ORTHOPEDICS CORPORATION
13-8595
Not in Commercial Distribution

  • 10889981003005 ()

  • 8.5 x 95mm
13-8595

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 90mm
SEASPINE ORTHOPEDICS CORPORATION
13-8590
In Commercial Distribution

  • 10889981002992 ()

  • 8.5 x 90mm
13-8590

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
13-8585
Not in Commercial Distribution

  • 10889981002985 ()

  • 8.5 x 85mm
13-8585

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 80mm
SEASPINE ORTHOPEDICS CORPORATION
13-8580
In Commercial Distribution

  • 10889981002978 ()

  • 8.5 x 80mm
13-8580

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
13-8575
Not in Commercial Distribution

  • 10889981002961 ()

  • 8.5 x 75mm
13-8575

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
13-8570
Not in Commercial Distribution

  • 10889981002954 ()

  • 8.5 x 70mm
13-8570

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
13-8565
Not in Commercial Distribution

  • 10889981002947 ()

  • 8.5 x 65mm
13-8565

  • 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 55mm
SEASPINE ORTHOPEDICS CORPORATION
13-8555
Not in Commercial Distribution

  • 10889981002923 ()

  • 8.5 x 55mm
13-8555

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
13-8550
Not in Commercial Distribution

  • 10889981002916 ()

  • 8.5 x 50mm
13-8550

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
13-8545
Not in Commercial Distribution

  • 10889981002909 ()

  • 8.5 x 45mm
13-8545

  • 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 35m
SEASPINE ORTHOPEDICS CORPORATION
13-8535
Not in Commercial Distribution

  • 10889981002886 ()

  • 8.5 x 35m
13-8535

  • 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 105mm
SEASPINE ORTHOPEDICS CORPORATION
13-8505
Not in Commercial Distribution

  • 10889981002855 ()

  • 8.5 x 105mm
13-8505

  • 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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