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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Malibu Polyaxial Screw,6.5 x 25mm
Seaspine, Inc.
12-6525
Not in Commercial Distribution

  • M5561265251 ()
  • 10381780012467 ()

  • 6.5 x 25mm
12-6525

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,6.0 x 55mm
Seaspine, Inc.
12-6055
Not in Commercial Distribution

  • M5561260551 ()
  • 10381780012450 ()

  • 6.0 x 55mm
12-6055

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,6.0 x 50mm
Seaspine, Inc.
12-6050
Not in Commercial Distribution

  • M5561260501 ()
  • 10381780012443 ()

  • 6.0 x 50mm
12-6050

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,6.0 x 45mm
Seaspine, Inc.
12-6045
Not in Commercial Distribution

  • M5561260451 ()
  • 10381780012436 ()

  • 6.0 x 45mm
12-6045

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,6.0 x 40mm
Seaspine, Inc.
12-6040
Not in Commercial Distribution

  • M5561260401 ()
  • 10381780012429 ()

  • 6.0 x 40mm
12-6040

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,6.0 x 35mm
Seaspine, Inc.
12-6035
Not in Commercial Distribution

  • M5561260351 ()
  • 10381780012412 ()

  • 6.0 x 35mm
12-6035

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,6.0 x 30mm
Seaspine, Inc.
12-6030
Not in Commercial Distribution

  • M5561260301 ()
  • 10381780012405 ()

  • 6.0 x 30mm
12-6030

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,6.0 x 25mm
Seaspine, Inc.
12-6025
Not in Commercial Distribution

  • M5561260251 ()
  • 10381780012399 ()

  • 6.0 x 25mm
12-6025

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,5.5 x 55mm
Seaspine, Inc.
12-5555
Not in Commercial Distribution

  • M5561255551 ()
  • 10381780012382 ()

  • 5.5 x 55mm
12-5555

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,5.5 x 50mm
Seaspine, Inc.
12-5550
Not in Commercial Distribution

  • M5561255501 ()
  • 10381780012375 ()

  • 5.5 x 50mm
12-5550

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,5.5 x 45mm
Seaspine, Inc.
12-5545
Not in Commercial Distribution

  • M5561255451 ()
  • 10381780012368 ()

  • 5.5 x 45mm
12-5545

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,5.5 x 40mm
Seaspine, Inc.
12-5540
Not in Commercial Distribution

  • M5561255401 ()
  • 10381780012351 ()

  • 5.5 x 40mm
12-5540

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,5.5 x 35mm
Seaspine, Inc.
12-5535
Not in Commercial Distribution

  • M5561255351 ()
  • 10381780012344 ()

  • 5.5 x 35mm
12-5535

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,5.5 x 30mm
Seaspine, Inc.
12-5530
Not in Commercial Distribution

  • M5561255301 ()
  • 10381780012337 ()

  • 5.5 x 30mm
12-5530

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,5.5 x 25mm
Seaspine, Inc.
12-5525
Not in Commercial Distribution

  • M5561255251 ()
  • 10381780012320 ()

  • 5.5 x 25mm
12-5525

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,4.5 x 50mm
Seaspine, Inc.
12-4550
Not in Commercial Distribution

  • M5561245501 ()
  • 10381780012313 ()

  • 4.5 x 50mm
12-4550

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,4.5 x 45mm
Seaspine, Inc.
12-4545
Not in Commercial Distribution

  • M5561245451 ()
  • 10381780012306 ()

  • 4.5 x 45mm
12-4545

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,4.5 x 40mm
Seaspine, Inc.
12-4540
Not in Commercial Distribution

  • M5561245401 ()
  • 10381780012290 ()

  • 4.5 x 40mm
12-4540

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,4.5 x 35mm
Seaspine, Inc.
12-4535
Not in Commercial Distribution

  • M5561245351 ()
  • 10381780012283 ()

  • 4.5 x 35mm
12-4535

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,4.5 x 30mm
Seaspine, Inc.
12-4530
Not in Commercial Distribution

  • M5561245301 ()
  • 10381780012276 ()

  • 4.5 x 30mm
12-4530

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,4.5 x 25mm
Seaspine, Inc.
12-4525
Not in Commercial Distribution

  • M5561245251 ()
  • 10381780012269 ()

  • 4.5 x 25mm
12-4525

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw,4.5 x 20mm
Seaspine, Inc.
12-4520
Not in Commercial Distribution

  • M5561245201 ()
  • 10381780012252 ()

  • 4.5 x 20mm
12-4520

  • Bone-screw internal spinal fixation system, non-sterile
Locking Cap, 8.0
Seaspine, Inc.
12-0020
Not in Commercial Distribution

  • M5561200201 ()
  • 10381780012245 ()

  • 8
12-0020

  • Bone-screw internal spinal fixation system, non-sterile
LOCKING CAP
Seaspine, Inc.
12-0010
Not in Commercial Distribution

  • M5561200101 ()
  • 10381780012238 ()

  • None
12-0010

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 8.0 x 50mm
Seaspine, Inc.
11-8050
Not in Commercial Distribution

  • M5561180501 ()
  • 10381780012221 ()

  • 8.0 x 50mm
11-8050

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 8.0 x 45mm
Seaspine, Inc.
11-8045
Not in Commercial Distribution

  • M5561180451 ()
  • 10381780012214 ()

  • 8.0 x 45mm
11-8045

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 8.0 x 40mm
Seaspine, Inc.
11-8040
Not in Commercial Distribution

  • M5561180401 ()
  • 10381780012207 ()

  • 8.0 x 40mm
11-8040

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.75 x 55 mm
Seaspine, Inc.
11-6755
Not in Commercial Distribution

  • M5561167551 ()
  • 10381780012191 ()

  • 6.75 x 55 mm
11-6755

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.75 x 50 mm
Seaspine, Inc.
11-6750
Not in Commercial Distribution

  • M5561167501 ()
  • 10381780012184 ()

  • 6.75 x 50 mm
11-6750

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.75 x 45 mm
Seaspine, Inc.
11-6745
Not in Commercial Distribution

  • M5561167451 ()
  • 10381780012177 ()

  • 6.75 x 45 mm
11-6745

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.75 x 40 mm
Seaspine, Inc.
11-6740
Not in Commercial Distribution

  • M5561167401 ()
  • 10381780012160 ()

  • 6.75 x 40 mm
11-6740

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.75 x 35 mm
Seaspine, Inc.
11-6735
Not in Commercial Distribution

  • M5561167351 ()
  • 10381780012153 ()

  • 6.75 x 35 mm
11-6735

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 5.5 x 50 mm
Seaspine, Inc.
11-5550
Not in Commercial Distribution

  • M5561155501 ()
  • 10381780012146 ()

  • 5.5 x 50 mm
11-5550

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 5.5 x 45 mm
Seaspine, Inc.
11-5545
Not in Commercial Distribution

  • M5561155451 ()
  • 10381780012139 ()

  • 5.5 x 45 mm
11-5545

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 5.5 x 40 mm
Seaspine, Inc.
11-5540
Not in Commercial Distribution

  • M5561155401 ()
  • 10381780012122 ()

  • 5.5 x 40 mm
11-5540

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 5.5 x 35 mm
Seaspine, Inc.
11-5535
Not in Commercial Distribution

  • M5561155351 ()
  • 10381780012115 ()

  • 5.5 x 35 mm
11-5535

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 5.5 x 30 mm
Seaspine, Inc.
11-5530
Not in Commercial Distribution

  • M5561155301 ()
  • 10381780012108 ()

  • 5.5 x 30 mm
11-5530

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 5.5 x 25 mm
Seaspine, Inc.
11-5525
Not in Commercial Distribution

  • M5561155251 ()
  • 10381780012092 ()

  • 5.5 x 25 mm
11-5525

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 8.0 x 60 mm
Seaspine, Inc.
10-8060
Not in Commercial Distribution

  • M5561080601 ()
  • 10381780012085 ()

  • 8.0 x 60 mm
10-8060

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 8.0 x 55 mm
Seaspine, Inc.
10-8055
Not in Commercial Distribution

  • M5561080551 ()
  • 10381780012078 ()

  • 8.0 x 55 mm
10-8055

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 8.0 x 50 mm
Seaspine, Inc.
10-8050
Not in Commercial Distribution

  • M5561080501 ()
  • 10381780012061 ()

  • 8.0 x 50 mm
10-8050

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 8.0 x 45 mm
Seaspine, Inc.
10-8045
Not in Commercial Distribution

  • M5561080451 ()
  • 10381780012054 ()

  • 8.0 x 45 mm
10-8045

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 8.0 x 40 mm
Seaspine, Inc.
10-8040
Not in Commercial Distribution

  • M5561080401 ()
  • 10381780012047 ()

  • 8.0 x 40 mm
10-8040

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 8.0 x 35 mm
Seaspine, Inc.
10-8035
Not in Commercial Distribution

  • M5561080351 ()
  • 10381780012030 ()

  • 8.0 x 35 mm
10-8035

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 6.75 x 60 mm
Seaspine, Inc.
10-6760
Not in Commercial Distribution

  • M5561067601 ()
  • 10381780012023 ()

  • 6.75 x 60 mm
10-6760

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 6.75 x 55 mm
Seaspine, Inc.
10-6755
Not in Commercial Distribution

  • M5561067551 ()
  • 10381780012016 ()

  • 6.75 x 55 mm
10-6755

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 6.75 x 50 mm
Seaspine, Inc.
10-6750
Not in Commercial Distribution

  • M5561067501 ()
  • 10381780012009 ()

  • 6.75 x 50 mm
10-6750

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 6.75 x 45 mm
Seaspine, Inc.
10-6745
Not in Commercial Distribution

  • M5561067451 ()
  • 10381780011996 ()

  • 6.75 x 45 mm
10-6745

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 6.75 x 40 mm
Seaspine, Inc.
10-6740
Not in Commercial Distribution

  • M5561067401 ()
  • 10381780011989 ()

  • 6.75 x 40 mm
10-6740

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 6.75 x 35 mm
Seaspine, Inc.
10-6735
Not in Commercial Distribution

  • M5561067351 ()
  • 10381780011972 ()

  • 6.75 x 35 mm
10-6735

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