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

  • Spinal bone screw, non-bioabsorbable
Newport 4.75 X 45mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4745
In Commercial Distribution

  • 10889981138806 ()

  • 4.75 X 45mm
61-4745

  • Spinal bone screw, non-bioabsorbable
Newport 4.75 X 40mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4740
In Commercial Distribution

  • 10889981138790 ()

  • 4.75 X 40mm
61-4740

  • Spinal bone screw, non-bioabsorbable
Newport 4.75 X 35mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4735
In Commercial Distribution

  • 10889981138783 ()

  • 4.75 X 35mm
61-4735

  • Spinal bone screw, non-bioabsorbable
Newport 4.75 X 30mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4730
In Commercial Distribution

  • 10889981138776 ()

  • 4.75 X 30mm
61-4730

  • Spinal bone screw, non-bioabsorbable
Cannulated Polyaxial Screw, 7.5mm x 45mm
Seaspine, Inc.
18-7545
Not in Commercial Distribution

  • M5561875451 ()
  • 10381780018902 ()

  • 7.5mm x 45mm
18-7545

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 6.5 x 50mm
Seaspine, Inc.
18-6550
Not in Commercial Distribution

  • M5561865501 ()
  • 10381780018889 ()

  • 6.5 x 50mm
18-6550

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 9.5 x 50mm
Seaspine, Inc.
16-9550
Not in Commercial Distribution

  • M5561695501 ()
  • 10381780013372 ()

  • 9.5 x 50mm
16-9550

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 9.5 x 35mm
Seaspine, Inc.
16-9535
Not in Commercial Distribution

  • M5561695351 ()
  • 10381780013341 ()

  • 9.5 x 35mm
16-9535

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 8.5 x 55mm
Seaspine, Inc.
16-8555
Not in Commercial Distribution

  • M5561685551 ()
  • 10381780013334 ()

  • 8.5 x 55mm
16-8555

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 8.5 x 40mm
Seaspine, Inc.
16-8540
Not in Commercial Distribution

  • M5561685401 ()
  • 10381780013303 ()

  • 8.5 x 40mm
16-8540

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 7.5 x 55mm
Seaspine, Inc.
16-7555
Not in Commercial Distribution

  • M5561675551 ()
  • 10381780013280 ()

  • 7.5 x 55mm
16-7555

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 7.5 x 40mm
Seaspine, Inc.
16-7540
Not in Commercial Distribution

  • M5561675401 ()
  • 10381780013259 ()

  • 7.5 x 40mm
16-7540

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 6.5 x 35mm
Seaspine, Inc.
16-6535
Not in Commercial Distribution

  • M5561665351 ()
  • 10381780013198 ()

  • 6.5 x 35mm
16-6535

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 5.5 x 50mm
Seaspine, Inc.
16-5550
Not in Commercial Distribution

  • M5561655501 ()
  • 10381780013181 ()

  • 5.5 x 50mm
16-5550

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 5.5 x 40mm
Seaspine, Inc.
16-5540
Not in Commercial Distribution

  • M5561655401 ()
  • 10381780013167 ()

  • 5.5 x 40mm
16-5540

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 5.5 x 30mm
Seaspine, Inc.
16-5530
Not in Commercial Distribution

  • M5561655301 ()
  • 10381780013143 ()

  • 5.5 x 30mm
16-5530

  • Bone-screw internal spinal fixation system, non-sterile
SetScrew, LP
Seaspine, Inc.
14-0010
Not in Commercial Distribution

  • M5561400101 ()
  • 10381780013082 ()

  • LP
14-0010

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 50mm
Seaspine, Inc.
13-7550
Not in Commercial Distribution

  • M5561375501 ()
  • 10381780013068 ()

  • 7.5 x 50mm
13-7550

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 45mm
Seaspine, Inc.
13-7545
Not in Commercial Distribution

  • M5561375451 ()
  • 10381780013051 ()

  • 7.5 x 45mm
13-7545

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 35mm
Seaspine, Inc.
13-7535
Not in Commercial Distribution

  • M5561375351 ()
  • 10381780013037 ()

  • 7.5 x 35mm
13-7535

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,6.5 x 45mm
Seaspine, Inc.
13-6545
Not in Commercial Distribution

  • M5561365451 ()
  • 10381780013006 ()

  • 6.5 x 45mm
13-6545

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,6.5 x 35mm
Seaspine, Inc.
13-6535
Not in Commercial Distribution

  • M5561365351 ()
  • 10381780012986 ()

  • 6.5 x 35mm
13-6535

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 50mm
Seaspine, Inc.
13-5550
Not in Commercial Distribution

  • M5561355501 ()
  • 10381780012979 ()

  • 5.5 x 50mm
13-5550

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 40mm
Seaspine, Inc.
13-5540
Not in Commercial Distribution

  • M5561355401 ()
  • 10381780012955 ()

  • 5.5 x 40mm
13-5540

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,5.5 x 25mm
Seaspine, Inc.
13-5525
Not in Commercial Distribution

  • M5561355251 ()
  • 10381780012924 ()

  • 5.5 x 25mm
13-5525

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,4.5 x 35mm
Seaspine, Inc.
13-4535
Not in Commercial Distribution

  • M5561345351 ()
  • 10381780012900 ()

  • 4.5 x 35mm
13-4535

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,4.5 x 30mm
Seaspine, Inc.
13-4530
Not in Commercial Distribution

  • M5561345301 ()
  • 10381780012894 ()

  • 4.5 x 30mm
13-4530

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 90mm
Seaspine, Inc.
12-8590
Not in Commercial Distribution

  • M5561285901 ()
  • 10381780012870 ()

  • 8.5 x 90mm
12-8590

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 8.5 x 80mm
Seaspine, Inc.
12-8580
Not in Commercial Distribution

  • M5561285801 ()
  • 10381780012863 ()

  • 8.5 x 80mm
12-8580

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