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 Polyaxial Reduction Screw,6.0 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
13-6035
Not in Commercial Distribution

  • 10889981002152 ()

  • 6.0 x 35mm
13-6035

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,6.0 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
13-6030
Not in Commercial Distribution

  • 10889981002145 ()

  • 6.0 x 30mm
13-6030

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw, 6.0 x 25mm
SEASPINE ORTHOPEDICS CORPORATION
13-6025
Not in Commercial Distribution

  • 10889981002138 ()

  • 6.0 x 25mm
13-6025

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
13-5560
Not in Commercial Distribution

  • 10889981002121 ()

  • 5.5 x 60mm
13-5560

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
13-5555
Not in Commercial Distribution

  • 10889981002114 ()

  • 5.5 x 55mm
13-5555

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
13-5550
In Commercial Distribution

  • 10889981002107 ()

  • 5.5 x 50mm
13-5550

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
13-5545
In Commercial Distribution

  • 10889981002091 ()

  • 5.5 x 45mm
13-5545

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
13-5540
In Commercial Distribution

  • 10889981002084 ()

  • 5.5 x 40mm
13-5540

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
13-5535
In Commercial Distribution

  • 10889981002077 ()

  • 5.5 x 35mm
13-5535

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
13-5530
In Commercial Distribution

  • 10889981002060 ()

  • 5.5 x 30mm
13-5530

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 25mm
SEASPINE ORTHOPEDICS CORPORATION
13-5525
In Commercial Distribution

  • 10889981002053 ()

  • 5.5 x 25mm
13-5525

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.0 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
13-5060
Not in Commercial Distribution

  • 10889981002046 ()

  • 5.0 x 60mm
13-5060

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.0 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
13-5055
Not in Commercial Distribution

  • 10889981002039 ()

  • 5.0 x 55mm
13-5055

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.0 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
13-5050
Not in Commercial Distribution

  • 10889981002022 ()

  • 5.0 x 50mm
13-5050

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.0 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
13-5045
Not in Commercial Distribution

  • 10889981002015 ()

  • 5.0 x 45mm
13-5045

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.0 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
13-5040
Not in Commercial Distribution

  • 10889981002008 ()

  • 5.0 x 40mm
13-5040

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.0 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
13-5035
Not in Commercial Distribution

  • 10889981001995 ()

  • 5.0 x 35mm
13-5035

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.0 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
13-5030
Not in Commercial Distribution

  • 10889981001988 ()

  • 5.0 x 30mm
13-5030

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.0 x 25mm
SEASPINE ORTHOPEDICS CORPORATION
13-5025
Not in Commercial Distribution

  • 10889981001971 ()

  • 5.0 x 25mm
13-5025

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,4.5 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
13-4560
Not in Commercial Distribution

  • 10889981001964 ()

  • 4.5 x 60mm
13-4560

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,4.5 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
13-4555
Not in Commercial Distribution

  • 10889981001957 ()

  • 4.5 x 55mm
13-4555

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,4.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
13-4550
Not in Commercial Distribution

  • 10889981001940 ()

  • 4.5 x 50mm
13-4550

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,4.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
13-4545
Not in Commercial Distribution

  • 10889981001933 ()

  • 4.5 x 45mm
13-4545

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,4.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
13-4540
In Commercial Distribution

  • 10889981001926 ()

  • 4.5 x 40mm
13-4540

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,4.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
13-4535
In Commercial Distribution

  • 10889981001919 ()

  • 4.5 x 35mm
13-4535

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,4.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
13-4530
In Commercial Distribution

  • 10889981001902 ()

  • 4.5 x 30mm
13-4530

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,4.5 x 25mm
SEASPINE ORTHOPEDICS CORPORATION
13-4525
In Commercial Distribution

  • 10889981001896 ()

  • 4.5 x 25mm
13-4525

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,4.5 x 20mm
SEASPINE ORTHOPEDICS CORPORATION
13-4520
Not in Commercial Distribution

  • 10889981001889 ()

  • 4.5 x 20mm
13-4520

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 95mm
SEASPINE ORTHOPEDICS CORPORATION
12-8595
Not in Commercial Distribution

  • 10889981001872 ()

  • 8.5 x 95mm
12-8595

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 90mm
SEASPINE ORTHOPEDICS CORPORATION
12-8590
In Commercial Distribution

  • 10889981001865 ()

  • 8.5 x 90mm
12-8590

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
12-8585
Not in Commercial Distribution

  • 10889981001858 ()

  • 8.5 x 85mm
12-8585

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 80mm
SEASPINE ORTHOPEDICS CORPORATION
12-8580
In Commercial Distribution

  • 10889981001841 ()

  • 8.5 x 80mm
12-8580

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
12-8575
In Commercial Distribution

  • 10889981001834 ()

  • 8.5 x 75mm
12-8575

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
12-8570
In Commercial Distribution

  • 10889981001827 ()

  • 8.5 x 70mm
12-8570

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
12-8565
In Commercial Distribution

  • 10889981001810 ()

  • 8.5 x 65mm
12-8565

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
12-8560
In Commercial Distribution

  • 10889981001803 ()

  • 8.5 x 60mm
12-8560

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
12-8555
In Commercial Distribution

  • 10889981001797 ()

  • 8.5 x 55mm
12-8555

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
12-8550
In Commercial Distribution

  • 10889981001780 ()

  • 8.5 x 50mm
12-8550

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
12-8545
In Commercial Distribution

  • 10889981001773 ()

  • 8.5 x 45mm
12-8545

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
12-8540
In Commercial Distribution

  • 10889981001766 ()

  • 8.5 x 40mm
12-8540

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