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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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Malibu - 10381780002246

Malibu Polyaxial Reduction Screw,8.5 x 110mm
Seaspine, Inc.
13-8510
Not in Commercial Distribution

  • M5561385101 ()
  • 10381780002246 ()

  • 8.5 x 110mm
13-8510

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

Malibu - 10381780002215

Malibu Polyaxial Reduction Screw,8.0 x 95mm
Seaspine, Inc.
13-8095
Not in Commercial Distribution

  • M5561380951 ()
  • 10381780002215 ()

  • 8.0 x 95mm
13-8095

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

Malibu - 10381780002192

Malibu Polyaxial Reduction Screw,8.0 x 85mm
Seaspine, Inc.
13-8085
Not in Commercial Distribution

  • M5561380851 ()
  • 10381780002192 ()

  • 8.0 x 85mm
13-8085

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

Malibu - 10381780002161

Malibu Polyaxial Reduction Screw,8.0 x 70mm
Seaspine, Inc.
13-8070
Not in Commercial Distribution

  • M5561380701 ()
  • 10381780002161 ()

  • 8.0 x 70mm
13-8070

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

Malibu - 10381780002154

Malibu Polyaxial Reduction Screw,8.0 x 65mm
Seaspine, Inc.
13-8065
Not in Commercial Distribution

  • M5561380651 ()
  • 10381780002154 ()

  • 8.0 x 65mm
13-8065

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

Malibu - 10381780002123

Malibu Polyaxial Reduction Screw,8.0 x 50mm
Seaspine, Inc.
13-8050
Not in Commercial Distribution

  • M5561380501 ()
  • 10381780002123 ()

  • 8.0 x 50mm
13-8050

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

Malibu - 10381780001850

Malibu Polyaxial Reduction Screw,7.0 x 40mm
Seaspine, Inc.
13-7040
Not in Commercial Distribution

  • M5561370401 ()
  • 10381780001850 ()

  • 7.0 x 40mm
13-7040

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

Malibu - 10381780001836

Malibu Polyaxial Reduction Screw,7.0 x 30mm
Seaspine, Inc.
13-7030
Not in Commercial Distribution

  • M5561370301 ()
  • 10381780001836 ()

  • 7.0 x 30mm
13-7030

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

Malibu - 10381780001805

Malibu Polyaxial Reduction Screw,6.5 x 90mm
Seaspine, Inc.
13-6590
Not in Commercial Distribution

  • M5561365901 ()
  • 10381780001805 ()

  • 6.5 x 90mm
13-6590

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

SeaSpine® Spacer System - Redondo - 10889981120481

Removal Handle
SEASPINE ORTHOPEDICS CORPORATION
93-6201
In Commercial Distribution

  • 10889981120481 ()
93-6201

  • Surgical instrument handle, non-torque-limiting
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