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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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SeaSpine NewPort Spinal System - 10889981138813

Newport 4.75 X 50mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4750
In Commercial Distribution

  • 10889981138813 ()

  • 4.75 X 50mm
61-4750

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

SeaSpine NewPort Spinal System - 10889981138806

Newport 4.75 X 45mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4745
In Commercial Distribution

  • 10889981138806 ()

  • 4.75 X 45mm
61-4745

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

SeaSpine NewPort Spinal System - 10889981138790

Newport 4.75 X 40mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4740
In Commercial Distribution

  • 10889981138790 ()

  • 4.75 X 40mm
61-4740

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

SeaSpine NewPort Spinal System - 10889981138783

Newport 4.75 X 35mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4735
In Commercial Distribution

  • 10889981138783 ()

  • 4.75 X 35mm
61-4735

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

SeaSpine NewPort Spinal System - 10889981138776

Newport 4.75 X 30mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4730
In Commercial Distribution

  • 10889981138776 ()

  • 4.75 X 30mm
61-4730

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

UCR - 10381780009283

Cap, 8mm
Seaspine, Inc.
10-0028
Not in Commercial Distribution

  • M5561000281 ()
  • 10381780009283 ()

  • 8mm
10-0028

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

UCR - 10381780009276

Cap, 5.5/6.75mm
Seaspine, Inc.
10-0026
Not in Commercial Distribution

  • M5561000261 ()
  • 10381780009276 ()

  • 5.5/6.75mm
10-0026

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

UCR - 10381780009269

SetScrew, 8mm
Seaspine, Inc.
10-0018
Not in Commercial Distribution

  • M5561000181 ()
  • 10381780009269 ()

  • 8mm
10-0018

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

UCR - 10381780009252

SetScrew, 5.5/6.75mm
Seaspine, Inc.
10-0016
Not in Commercial Distribution

  • M5561000161 ()
  • 10381780009252 ()

  • 5.5/6.75mm
10-0016

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

Malibu - 10381780009245

Cannulated Uni-Planar Dlta Screw Ø7.5 x 80mm
Seaspine, Inc.
75-7580
Not in Commercial Distribution

  • M5567575801 ()
  • 10381780009245 ()

  • Ø7.5 x 80mm
75-7580

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

Malibu - 10381780009238

Cannulated Uni-Planar Dlta Screw Ø7.5 x 75mm
Seaspine, Inc.
75-7575
Not in Commercial Distribution

  • M5567575751 ()
  • 10381780009238 ()

  • Ø7.5 x 75mm
75-7575

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

Malibu - 10381780009221

Cannulated Uni-Planar Dlta Screw Ø7.5 x 70mm
Seaspine, Inc.
75-7570
Not in Commercial Distribution

  • M5567575701 ()
  • 10381780009221 ()

  • Ø7.5 x 70mm
75-7570

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

Malibu - 10381780009214

Cannulated Uni-Planar Dlta Screw Ø7.5 x 65mm
Seaspine, Inc.
75-7565
Not in Commercial Distribution

  • M5567575651 ()
  • 10381780009214 ()

  • Ø7.5 x 65mm
75-7565

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

Malibu - 10381780009207

Cannulated Uni-Planar Dlta Screw Ø7.5 x 60mm
Seaspine, Inc.
75-7560
Not in Commercial Distribution

  • M5567575601 ()
  • 10381780009207 ()

  • Ø7.5 x 60mm
75-7560

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

Malibu - 10381780009191

Cannulated Uni-Planar Dlta Screw Ø7.5 x 55mm
Seaspine, Inc.
75-7555
Not in Commercial Distribution

  • M5567575551 ()
  • 10381780009191 ()

  • Ø7.5 x 55mm
75-7555

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

Malibu - 10381780009184

Cannulated Uni-Planar Dlta Screw Ø7.5 x 50mm
Seaspine, Inc.
75-7550
Not in Commercial Distribution

  • M5567575501 ()
  • 10381780009184 ()

  • Ø7.5 x 50mm
75-7550

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

Malibu - 10381780009177

Cannulated Uni-Planar Dlta Screw Ø7.5 x 45mm
Seaspine, Inc.
75-7545
Not in Commercial Distribution

  • M5567575451 ()
  • 10381780009177 ()

  • Ø7.5 x 45mm
75-7545

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

Malibu - 10381780009160

Cannulated Uni-Planar Dlta Screw Ø7.5 x 40mm
Seaspine, Inc.
75-7540
Not in Commercial Distribution

  • M5567575401 ()
  • 10381780009160 ()

  • Ø7.5 x 40mm
75-7540

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

Malibu - 10381780009153

Cannulated Uni-Planar Dlta Screw Ø7.5 x 35mm
Seaspine, Inc.
75-7535
Not in Commercial Distribution

  • M5567575351 ()
  • 10381780009153 ()

  • Ø7.5 x 35mm
75-7535

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

Malibu - 10381780009146

Cannulated Uni-Planar Dlta Screw Ø7.5 x 30mm
Seaspine, Inc.
75-7530
Not in Commercial Distribution

  • M5567575301 ()
  • 10381780009146 ()

  • Ø7.5 x 30mm
75-7530

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

Malibu - 10381780009139

Cannulated Uni-Planar Dlta Screw Ø7.5 x 25mm
Seaspine, Inc.
75-7525
Not in Commercial Distribution

  • M5567575251 ()
  • 10381780009139 ()

  • Ø7.5 x 25mm
75-7525

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

Malibu - 10381780009122

Cannulated Uni-Planar Dlta Screw Ø7.0 x 70mm
Seaspine, Inc.
75-7070
Not in Commercial Distribution

  • M5567570701 ()
  • 10381780009122 ()

  • Ø7.0 x 70mm
75-7070

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

Malibu - 10381780009115

Cannulated Uni-Planar Dlta Screw Ø7.0 x 65mm
Seaspine, Inc.
75-7065
Not in Commercial Distribution

  • M5567570651 ()
  • 10381780009115 ()

  • Ø7.0 x 65mm
75-7065

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

Malibu - 10381780009108

Cannulated Uni-Planar Dlta Screw Ø7.0 x 60mm
Seaspine, Inc.
75-7060
Not in Commercial Distribution

  • M5567570601 ()
  • 10381780009108 ()

  • Ø7.0 x 60mm
75-7060

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

Malibu - 10381780009092

Cannulated Uni-Planar Dlta Screw Ø7.0 x 55mm
Seaspine, Inc.
75-7055
Not in Commercial Distribution

  • M5567570551 ()
  • 10381780009092 ()

  • Ø7.0 x 55mm
75-7055

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

Malibu - 10381780009085

Cannulated Uni-Planar Dlta Screw Ø7.0 x 50mm
Seaspine, Inc.
75-7050
Not in Commercial Distribution

  • M5567570501 ()
  • 10381780009085 ()

  • Ø7.0 x 50mm
75-7050

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

Malibu - 10381780009078

Cannulated Uni-Planar Dlta Screw Ø7.0 x 45mm
Seaspine, Inc.
75-7045
Not in Commercial Distribution

  • M5567570451 ()
  • 10381780009078 ()

  • Ø7.0 x 45mm
75-7045

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

Malibu - 10381780009061

Cannulated Uni-Planar Dlta Screw Ø7.0 x 40mm
Seaspine, Inc.
75-7040
Not in Commercial Distribution

  • M5567570401 ()
  • 10381780009061 ()

  • Ø7.0 x 40mm
75-7040

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

Malibu - 10381780009054

Cannulated Uni-Planar Dlta Screw Ø7.0 x 35mm
Seaspine, Inc.
75-7035
Not in Commercial Distribution

  • M5567570351 ()
  • 10381780009054 ()

  • Ø7.0 x 35mm
75-7035

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

Malibu - 10381780009047

Cannulated Uni-Planar Dlta Screw Ø7.0 x 30mm
Seaspine, Inc.
75-7030
Not in Commercial Distribution

  • M5567570301 ()
  • 10381780009047 ()

  • Ø7.0 x 30mm
75-7030

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

Malibu - 10381780009030

Cannulated Uni-Planar Dlta Screw Ø7.0 x 25mm
Seaspine, Inc.
75-7025
Not in Commercial Distribution

  • M5567570251 ()
  • 10381780009030 ()

  • Ø7.0 x 25mm
75-7025

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

Malibu - 10381780009023

Cannulated Uni-Planar Dlta Screw Ø6.5 x 95mm
Seaspine, Inc.
75-6595
Not in Commercial Distribution

  • M5567565951 ()
  • 10381780009023 ()

  • Ø6.5 x 95mm
75-6595

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

Malibu - 10381780009016

Cannulated Uni-Planar Dlta Screw Ø6.5 x 90mm
Seaspine, Inc.
75-6590
Not in Commercial Distribution

  • M5567565901 ()
  • 10381780009016 ()

  • Ø6.5 x 90mm
75-6590

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

Malibu - 10381780009009

Cannulated Uni-Planar Dlta Screw Ø6.5 x 85mm
Seaspine, Inc.
75-6585
Not in Commercial Distribution

  • M5567565851 ()
  • 10381780009009 ()

  • Ø6.5 x 85mm
75-6585

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

Malibu - 10381780008996

Cannulated Uni-Planar Dlta Screw Ø6.5 x 80mm
Seaspine, Inc.
75-6580
Not in Commercial Distribution

  • M5567565801 ()
  • 10381780008996 ()

  • Ø6.5 x 80mm
75-6580

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

Malibu - 10381780008989

Cannulated Uni-Planar Dlta Screw Ø6.5 x 75mm
Seaspine, Inc.
75-6575
Not in Commercial Distribution

  • M5567565751 ()
  • 10381780008989 ()

  • Ø6.5 x 75mm
75-6575

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

Malibu - 10381780008972

Cannulated Uni-Planar Dlta Screw Ø6.5 x 70mm
Seaspine, Inc.
75-6570
Not in Commercial Distribution

  • M5567565701 ()
  • 10381780008972 ()

  • Ø6.5 x 70mm
75-6570

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

Malibu - 10381780008965

Cannulated Uni-Planar Dlta Screw Ø6.5 x 65mm
Seaspine, Inc.
75-6565
Not in Commercial Distribution

  • M5567565651 ()
  • 10381780008965 ()

  • Ø6.5 x 65mm
75-6565

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

Malibu - 10381780008958

Cannulated Uni-Planar Dlta Screw Ø6.5 x 60mm
Seaspine, Inc.
75-6560
Not in Commercial Distribution

  • M5567565601 ()
  • 10381780008958 ()

  • ؘ6.5 x 60mm
75-6560

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

Malibu - 10381780008941

Cannulated Uni-Planar Dlta Screw Ø6.5 x 55mm
Seaspine, Inc.
75-6555
Not in Commercial Distribution

  • M5567565551 ()
  • 10381780008941 ()

  • Ø6.5 x 55mm
75-6555

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

Malibu - 10381780008934

Cannulated Uni-Planar Dlta Screw Ø6.5 x 50mm
Seaspine, Inc.
75-6550
Not in Commercial Distribution

  • M5567565501 ()
  • 10381780008934 ()

  • Ø6.5 x 50mm
75-6550

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

Malibu - 10381780008927

Cannulated Uni-Planar Dlta Screw Ø6.5 x 45mm
Seaspine, Inc.
75-6545
Not in Commercial Distribution

  • M5567565451 ()
  • 10381780008927 ()

  • Ø6.5 x 45mm
75-6545

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

Malibu - 10381780008910

Cannulated Uni-Planar Dlta Screw Ø6.5 x 40mm
Seaspine, Inc.
75-6540
Not in Commercial Distribution

  • M5567565401 ()
  • 10381780008910 ()

  • Ø6.5 x 40mm
75-6540

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

Malibu - 10381780008903

Cannulated Uni-Planar Dlta Screw Ø6.5 x 35mm
Seaspine, Inc.
75-6535
Not in Commercial Distribution

  • M5567565351 ()
  • 10381780008903 ()

  • Ø6.5 x 35mm
75-6535

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

Malibu - 10381780008897

Cannulated Uni-Planar Dlta Screw Ø6.5 x 30mm
Seaspine, Inc.
75-6530
Not in Commercial Distribution

  • M5567565301 ()
  • 10381780008897 ()

  • Ø6.5 x 30mm
75-6530

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

Malibu - 10381780008880

Cannulated Uni-Planar Dlta Screw Ø6.5 x 25mm
Seaspine, Inc.
75-6525
Not in Commercial Distribution

  • M5567565251 ()
  • 10381780008880 ()

  • Ø6.5 x 25mm
75-6525

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

Malibu - 10381780008873

Cannulated Uni-Planar Dlta Screw Ø6.5 x 110mm
Seaspine, Inc.
75-6510
Not in Commercial Distribution

  • M5567565101 ()
  • 10381780008873 ()

  • Ø6.5 x 110mm
75-6510

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

Malibu - 10381780008866

Cannulated Uni-Planar Dlta Screw Ø6.5 x 105mm
Seaspine, Inc.
75-6505
Not in Commercial Distribution

  • M5567565051 ()
  • 10381780008866 ()

  • Ø6.5 x 105mm
75-6505

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

Malibu - 10381780008859

Cannulated Uni-Planar Dlta Screw Ø6.5 x 100mm
Seaspine, Inc.
75-6500
Not in Commercial Distribution

  • M5567565001 ()
  • 10381780008859 ()

  • Ø6.5 x 100mm
75-6500

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

Malibu - 10381780008842

Cannulated Uni-Planar Dlta Screw Ø6.0 x 60mm
Seaspine, Inc.
75-6060
Not in Commercial Distribution

  • M5567560601 ()
  • 10381780008842 ()

  • Ø6.0 x 60mm
75-6060

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