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,8.0 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
13-8075
Not in Commercial Distribution

  • 10889981002794 ()

  • 8.0 x 75mm
13-8075

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
13-8070
Not in Commercial Distribution

  • 10889981002787 ()

  • 8.0 x 70mm
13-8070

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
13-8065
Not in Commercial Distribution

  • 10889981002770 ()

  • 8.0 x 65mm
13-8065

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
13-8060
Not in Commercial Distribution

  • 10889981002763 ()

  • 8.0 x 60mm
13-8060

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
13-8055
Not in Commercial Distribution

  • 10889981002756 ()

  • 8.0 x 55mm
13-8055

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
13-8050
Not in Commercial Distribution

  • 10889981002749 ()

  • 8.0 x 50mm
13-8050

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
13-8045
Not in Commercial Distribution

  • 10889981002732 ()

  • 8.0 x 45mm
13-8045

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
13-8040
Not in Commercial Distribution

  • 10889981002725 ()

  • 8.0 x 40mm
13-8040

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
13-8035
Not in Commercial Distribution

  • 10889981002718 ()

  • 8.0 x 35mm
13-8035

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
13-8030
Not in Commercial Distribution

  • 10889981002701 ()

  • 8.0 x 30mm
13-8030

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
13-8010
Not in Commercial Distribution

  • 10889981002695 ()

  • 8.0 x 110mm
13-8010

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 105mm
SEASPINE ORTHOPEDICS CORPORATION
13-8005
Not in Commercial Distribution

  • 10889981002688 ()

  • 8.0 x 105mm
13-8005

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 75mm
SEASPINE ORTHOPEDICS CORPORATION
71-6575
Not in Commercial Distribution

  • 10889981010386 ()

  • 6.5 DIA x 75mm
71-6575

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 70mm
SEASPINE ORTHOPEDICS CORPORATION
71-6570
Not in Commercial Distribution

  • 10889981010379 ()

  • 6.5 DIA x 70mm
71-6570

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 65mm
SEASPINE ORTHOPEDICS CORPORATION
71-6565
Not in Commercial Distribution

  • 10889981010362 ()

  • 6.5 DIA x 65mm
71-6565

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
71-6560
Not in Commercial Distribution

  • 10889981010355 ()

  • 6.5 DIA x 60mm
71-6560

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 55mm
SEASPINE ORTHOPEDICS CORPORATION
71-6555
Not in Commercial Distribution

  • 10889981010348 ()

  • 6.5 DIA x 55mm
71-6555

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
71-6550
In Commercial Distribution

  • 10889981010331 ()

  • 6.5 DIA x 50mm
71-6550

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
71-6545
In Commercial Distribution

  • 10889981010324 ()

  • 6.5 DIA x 45mm
71-6545

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
71-6540
In Commercial Distribution

  • 10889981010317 ()

  • 6.5 DIA x 40mm
71-6540

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
71-6535
In Commercial Distribution

  • 10889981010300 ()

  • 6.5 DIA x 35mm
71-6535

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
71-6530
Not in Commercial Distribution

  • 10889981010294 ()

  • 6.5 DIA x 30mm
71-6530

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
71-6525
Not in Commercial Distribution

  • 10889981010287 ()

  • 6.5 DIA x 25mm
71-6525

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 110mm
SEASPINE ORTHOPEDICS CORPORATION
71-6510
Not in Commercial Distribution

  • 10889981010270 ()

  • 6.5 DIA x 110mm
71-6510

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 105mm
SEASPINE ORTHOPEDICS CORPORATION
71-6505
Not in Commercial Distribution

  • 10889981010263 ()

  • 6.5 DIA x 105mm
71-6505

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.5 DIA x 100mm
SEASPINE ORTHOPEDICS CORPORATION
71-6500
Not in Commercial Distribution

  • 10889981010256 ()

  • 6.5 DIA x 100mm
71-6500

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.0 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
71-6060
Not in Commercial Distribution

  • 10889981010249 ()

  • 6.0 DIA x 60mm
71-6060

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.0 DIA x 55mm
SEASPINE ORTHOPEDICS CORPORATION
71-6055
Not in Commercial Distribution

  • 10889981010232 ()

  • 6.0 DIA x 55mm
71-6055

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.0 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
71-6050
Not in Commercial Distribution

  • 10889981010225 ()

  • 6.0 DIA x 50mm
71-6050

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.0 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
71-6045
Not in Commercial Distribution

  • 10889981010218 ()

  • 6.0 DIA x 45mm
71-6045

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.0 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
71-6040
Not in Commercial Distribution

  • 10889981010201 ()

  • 6.0 DIA x 40mm
71-6040

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.0 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
71-6035
Not in Commercial Distribution

  • 10889981010195 ()

  • 6.0 DIA x 35mm
71-6035

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.0 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
71-6030
Not in Commercial Distribution

  • 10889981010188 ()

  • 6.0 DIA x 30mm
71-6030

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 6.0 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
71-6025
Not in Commercial Distribution

  • 10889981010171 ()

  • 6.0 DIA x 25mm
71-6025

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 5.5 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
71-5560
Not in Commercial Distribution

  • 10889981010164 ()

  • 5.5 DIA x 60mm
71-5560

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 5.5 DIA x 55mm
SEASPINE ORTHOPEDICS CORPORATION
71-5555
Not in Commercial Distribution

  • 10889981010157 ()

  • 5.5 DIA x 55mm
71-5555

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 5.5 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
71-5550
Not in Commercial Distribution

  • 10889981010140 ()

  • 5.5 DIA x 50mm
71-5550

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 5.5 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
71-5545
In Commercial Distribution

  • 10889981010133 ()

  • 5.5 DIA x 45mm
71-5545

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 5.5 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
71-5540
In Commercial Distribution

  • 10889981010126 ()

  • 5.5 DIA x 40mm
71-5540

  • Bone-screw internal spinal fixation system, non-sterile
TSC Uni-Planar Reduction Screw, 5.5 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
71-5535
In Commercial Distribution

  • 10889981010119 ()

  • 5.5 DIA x 35mm
71-5535

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