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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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Newport - 10381780031352

NewPort Double Lead Screw, DIA 7.5 x 35mm
Seaspine, Inc.
61-7535
Not in Commercial Distribution

  • M5566175351 ()
  • 10381780031352 ()

  • DIA 7.5 x 35mm
61-7535

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

Newport - 10381780031345

NewPort Double Lead Screw, DIA 7.5 x 30mm
Seaspine, Inc.
61-7530
Not in Commercial Distribution

  • M5566175301 ()
  • 10381780031345 ()

  • DIA 7.5 x 30mm
61-7530

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

Newport - 10381780031338

NewPort Double Lead Screw, DIA 7.5 x 110mm
Seaspine, Inc.
61-7510
Not in Commercial Distribution

  • M5566175101 ()
  • 10381780031338 ()

  • DIA 7.5 x 110mm
61-7510

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

Malibu - 10381780003656

Cannulated Polyaxial Screw, 8.5 x 35MM
Seaspine, Inc.
18-8535
Not in Commercial Distribution

  • M5561885351 ()
  • 10381780003656 ()

  • 8.5 x 35MM
18-8535

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

Malibu - 10381780003649

Cannulated Polyaxial Screw, 8.5 x 30MM
Seaspine, Inc.
18-8530
Not in Commercial Distribution

  • M5561885301 ()
  • 10381780003649 ()

  • 8.5 x 30MM
18-8530

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

Malibu - 10381780003632

Cannulated Polyaxial Screw, 8.0 x 80MM
Seaspine, Inc.
18-8080
Not in Commercial Distribution

  • M5561880801 ()
  • 10381780003632 ()

  • 8.0 x 80MM
18-8080

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

Malibu - 10381780003625

Cannulated Polyaxial Screw, 8.0 x 75MM
Seaspine, Inc.
18-8075
Not in Commercial Distribution

  • M5561880751 ()
  • 10381780003625 ()

  • 8.0 x 75MM
18-8075

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

Malibu - 10381780003618

Cannulated Polyaxial Screw, 8.0 x 70MM
Seaspine, Inc.
18-8070
Not in Commercial Distribution

  • M5561880701 ()
  • 10381780003618 ()

  • 8.0 x 70MM
18-8070

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

Malibu - 10381780003601

Cannulated Polyaxial Screw, 8.0 x 65MM
Seaspine, Inc.
18-8065
Not in Commercial Distribution

  • M5561880651 ()
  • 10381780003601 ()

  • 8.0 x 65MM
18-8065

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

Malibu - 10381780003595

Cannulated Polyaxial Screw, 8.0 x 60MM
Seaspine, Inc.
18-8060
Not in Commercial Distribution

  • M5561880601 ()
  • 10381780003595 ()

  • 8.0 x 60MM
18-8060

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