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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 Device Size Type Device Class Implantable

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Coronal Bender, Fulcrum, Small Stature
SEASPINE ORTHOPEDICS CORPORATION
97-6134
In Commercial Distribution

  • 10889981139599 ()
97-6134

  • Bone-screw internal spinal fixation system, non-sterile
Torque Limiting Driver, 1/4 sq., 90 in-lb
SEASPINE ORTHOPEDICS CORPORATION
97-6090
In Commercial Distribution

  • 10889981139575 ()

  • 1/4 sq., 90 in-lb
97-6090

  • Orthopaedic implant driver
Thoracic Sounding Probe - Straight
SEASPINE ORTHOPEDICS CORPORATION
97-6113
In Commercial Distribution

  • 10889981139216 ()
97-6113

  • Neurosurgical probe
Rod Template, 3.5mm DIA
SEASPINE ORTHOPEDICS CORPORATION
97-6107
In Commercial Distribution

  • 10889981139193 ()

  • 3.5mm
97-6107

  • Surgical implant template, reusable
Coronal Bender 4.5mm Dia., Left
SEASPINE ORTHOPEDICS CORPORATION
97-6132
In Commercial Distribution

  • 10889981138691 ()

  • 4.5mm
97-6132

  • Manual orthopaedic bender, reusable
Rod Gripper, 4.5mm Dia.
SEASPINE ORTHOPEDICS CORPORATION
97-6109
In Commercial Distribution

  • 10889981138684 ()

  • 4.5mm
97-6109

  • Surgical implant/trial-implant/sizer holder, reusable
Tap 4.0mm, Cannulated (for 4.5mm Screw)
SEASPINE ORTHOPEDICS CORPORATION
97-6121
In Commercial Distribution

  • 10889981138516 ()

  • 4.0mm
97-6121

  • Bone tap, reusable
Counter Torque, Small Stature
SEASPINE ORTHOPEDICS CORPORATION
97-6103
In Commercial Distribution

  • 10889981136222 ()
97-6103

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 8.5 Dia. x 105mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-8505
In Commercial Distribution

  • 10889981132552 ()

  • 105mm
78-8505

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 8.5 Dia. x 95mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-8595
In Commercial Distribution

  • 10889981132538 ()

  • 95mm
78-8595

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 7.5 Dia. x 50mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-7550
In Commercial Distribution

  • 10889981132279 ()

  • 50mm
78-7550

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 7.5 Dia. x 40mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-7540
In Commercial Distribution

  • 10889981132255 ()

  • 40mm
78-7540

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 7.5 Dia. x 35mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-7535
In Commercial Distribution

  • 10889981132248 ()

  • 35mm
78-7535

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 7.5 Dia. x 30mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-7530
In Commercial Distribution

  • 10889981132231 ()

  • 30mm
78-7530

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 105mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6505
In Commercial Distribution

  • 10889981132217 ()

  • 105mm
78-6505

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 100mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6500
In Commercial Distribution

  • 10889981132200 ()

  • 100mm
78-6500

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 95mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6595
In Commercial Distribution

  • 10889981132194 ()

  • 95mm
78-6595

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 90mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6590
In Commercial Distribution

  • 10889981132187 ()

  • 90mm
78-6590

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 85mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6585
In Commercial Distribution

  • 10889981132170 ()

  • 85mm
78-6585

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 80mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6580
In Commercial Distribution

  • 10889981132163 ()

  • 80mm
78-6580

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 75mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6575
In Commercial Distribution

  • 10889981132156 ()

  • 75mm
78-6575

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 70mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6570
In Commercial Distribution

  • 10889981132149 ()

  • 70mm
78-6570

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 65mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6565
In Commercial Distribution

  • 10889981132132 ()

  • 65mm
78-6565

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 60mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6560
In Commercial Distribution

  • 10889981132125 ()

  • 60mm
78-6560

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 55mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6555
In Commercial Distribution

  • 10889981132118 ()

  • 55mm
78-6555

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 50mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6550
In Commercial Distribution

  • 10889981132101 ()

  • 50mm
78-6550

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.5 Dia. x 40mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6540
In Commercial Distribution

  • 10889981132088 ()

  • 40mm
78-6540

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.0 Dia. x 45mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6045
In Commercial Distribution

  • 10889981132019 ()

  • 45mm
78-6045

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.0 Dia. x 35mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6035
In Commercial Distribution

  • 10889981131999 ()

  • 35mm
78-6035

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 6.0 Dia. x 20mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
78-6020
In Commercial Distribution

  • 10889981131968 ()

  • 20mm
78-6020

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