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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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
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
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
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
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
Cannulated Dlta Polyaxial Screw, Ø6.5 x 40mm
Seaspine, Inc.
63-6540
Not in Commercial Distribution

  • M5566365401 ()
  • 10381780004585 ()

  • Ø6.5 x 40mm
63-6540

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 35mm
Seaspine, Inc.
63-6535
Not in Commercial Distribution

  • M5566365351 ()
  • 10381780004578 ()

  • Ø6.5 x 35mm
63-6535

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 30mm
Seaspine, Inc.
63-6530
Not in Commercial Distribution

  • M5566365301 ()
  • 10381780004561 ()

  • Ø6.5 x 30mm
63-6530

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 25mm
Seaspine, Inc.
63-6525
Not in Commercial Distribution

  • M5566365251 ()
  • 10381780004554 ()

  • Ø6.5 x 25mm
63-6525

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 110mm
Seaspine, Inc.
63-6510
Not in Commercial Distribution

  • M5566365101 ()
  • 10381780004547 ()

  • Ø6.5 x 110mm
63-6510

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 105mm
Seaspine, Inc.
63-6505
Not in Commercial Distribution

  • M5566365051 ()
  • 10381780004530 ()

  • Ø6.5 x 105mm
63-6505

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 100mm
Seaspine, Inc.
63-6500
Not in Commercial Distribution

  • M5566365001 ()
  • 10381780004523 ()

  • Ø6.5 x 100mm
63-6500

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 60mm
Seaspine, Inc.
63-6060
Not in Commercial Distribution

  • M5566360601 ()
  • 10381780004516 ()

  • Ø6.0 x 60mm
63-6060

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 55mm
Seaspine, Inc.
63-6055
Not in Commercial Distribution

  • M5566360551 ()
  • 10381780004509 ()

  • Ø6.0 x 55mm
63-6055

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 50mm
Seaspine, Inc.
63-6050
Not in Commercial Distribution

  • M5566360501 ()
  • 10381780004493 ()

  • Ø6.0 x 50mm
63-6050

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 45mm
Seaspine, Inc.
63-6045
Not in Commercial Distribution

  • M5566360451 ()
  • 10381780004486 ()

  • Ø6.0 x 45mm
63-6045

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 40mm
Seaspine, Inc.
63-6040
Not in Commercial Distribution

  • M5566360401 ()
  • 10381780004479 ()

  • Ø6.0 x 40mm
63-6040

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 35mm
Seaspine, Inc.
63-6035
Not in Commercial Distribution

  • M5566360351 ()
  • 10381780004462 ()

  • Ø6.0 x 35mm
63-6035

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 30mm
Seaspine, Inc.
63-6030
Not in Commercial Distribution

  • M5566360301 ()
  • 10381780004455 ()

  • Ø6.0 x 30mm
63-6030

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 25mm
Seaspine, Inc.
63-6025
Not in Commercial Distribution

  • M5566360251 ()
  • 10381780004448 ()

  • Ø6.0 x 25mm
63-6025

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø5.5 x 60mm
Seaspine, Inc.
63-5560
Not in Commercial Distribution

  • M5566355601 ()
  • 10381780004431 ()

  • Ø5.5 x 60mm
63-5560

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø5.5 x 55mm
Seaspine, Inc.
63-5555
Not in Commercial Distribution

  • M5566355551 ()
  • 10381780004424 ()

  • Ø5.5 x 55mm
63-5555

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø5.5 x 50mm
Seaspine, Inc.
63-5550
Not in Commercial Distribution

  • M5566355501 ()
  • 10381780004417 ()

  • Ø5.5 x 50mm
63-5550

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø5.5 x 45mm
Seaspine, Inc.
63-5545
Not in Commercial Distribution

  • M5566355451 ()
  • 10381780004400 ()

  • Ø5.5 x 45mm
63-5545

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø5.5 x 40mm
Seaspine, Inc.
63-5540
Not in Commercial Distribution

  • M5566355401 ()
  • 10381780004394 ()

  • Ø5.5 x 40mm
63-5540

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø5.5 x 35mm
Seaspine, Inc.
63-5535
Not in Commercial Distribution

  • M5566355351 ()
  • 10381780004387 ()

  • Ø5.5 x 35mm
63-5535

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø5.5 x 30mm
Seaspine, Inc.
63-5530
Not in Commercial Distribution

  • M5566355301 ()
  • 10381780004370 ()

  • Ø5.5 x 30mm
63-5530

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø5.5 x 25mm
Seaspine, Inc.
63-5525
Not in Commercial Distribution

  • M5566355251 ()
  • 10381780004363 ()

  • Ø5.5 x 25mm
63-5525

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 95mm
Seaspine, Inc.
62-7595
Not in Commercial Distribution

  • M5566275951 ()
  • 10381780004356 ()

  • Ø7.5 x 95mm
62-7595

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 90mm
Seaspine, Inc.
62-7590
Not in Commercial Distribution

  • M5566275901 ()
  • 10381780004349 ()

  • Ø7.5 x 90mm
62-7590

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 85mm
Seaspine, Inc.
62-7585
Not in Commercial Distribution

  • M5566275851 ()
  • 10381780004332 ()

  • Ø7.5 x 85mm
62-7585

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 80mm
Seaspine, Inc.
62-7580
Not in Commercial Distribution

  • M5566275801 ()
  • 10381780004325 ()

  • Ø7.5 x 80mm
62-7580

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 75mm
Seaspine, Inc.
62-7575
Not in Commercial Distribution

  • M5566275751 ()
  • 10381780004318 ()

  • Ø7.5 x 75mm
62-7575

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 70mm
Seaspine, Inc.
62-7570
Not in Commercial Distribution

  • M5566275701 ()
  • 10381780004301 ()

  • Ø7.5 x 70mm
62-7570

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 65mm
Seaspine, Inc.
62-7565
Not in Commercial Distribution

  • M5566275651 ()
  • 10381780004295 ()

  • Ø7.5 x 65mm
62-7565

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 60mm
Seaspine, Inc.
62-7560
Not in Commercial Distribution

  • M5566275601 ()
  • 10381780004288 ()

  • Ø7.5 x 60mm
62-7560

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 55mm
Seaspine, Inc.
62-7555
Not in Commercial Distribution

  • M5566275551 ()
  • 10381780004271 ()

  • Ø7.5 x 55mm
62-7555

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 50mm
Seaspine, Inc.
62-7550
Not in Commercial Distribution

  • M5566275501 ()
  • 10381780004264 ()

  • Ø7.5 x 50mm
62-7550

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 45mm
Seaspine, Inc.
62-7545
Not in Commercial Distribution

  • M5566275451 ()
  • 10381780004257 ()

  • Ø7.5 x 45mm
62-7545

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø7.5 x 40mm
Seaspine, Inc.
62-7540
Not in Commercial Distribution

  • M5566275401 ()
  • 10381780004240 ()

  • Ø7.5 x 40mm
62-7540

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