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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Cap, 8mm
Seaspine, Inc.
10-0028
Not in Commercial Distribution

  • M5561000281 ()
  • 10381780009283 ()

  • 8mm
10-0028

  • Bone-screw internal spinal fixation system, non-sterile
Cap, 5.5/6.75mm
Seaspine, Inc.
10-0026
Not in Commercial Distribution

  • M5561000261 ()
  • 10381780009276 ()

  • 5.5/6.75mm
10-0026

  • Bone-screw internal spinal fixation system, non-sterile
SetScrew, 8mm
Seaspine, Inc.
10-0018
Not in Commercial Distribution

  • M5561000181 ()
  • 10381780009269 ()

  • 8mm
10-0018

  • Bone-screw internal spinal fixation system, non-sterile
SetScrew, 5.5/6.75mm
Seaspine, Inc.
10-0016
Not in Commercial Distribution

  • M5561000161 ()
  • 10381780009252 ()

  • 5.5/6.75mm
10-0016

  • Bone-screw internal spinal fixation system, non-sterile
UCR Implant Tray
Seaspine, Inc.
UCRIMP
Not in Commercial Distribution

  • M556UCRIMP1 ()
  • 10381780023302 ()
UCRIMP

  • Bone-screw internal spinal fixation system, non-sterile
Cap, LP
Seaspine, Inc.
14-0020
Not in Commercial Distribution

  • M5561400201 ()
  • 10381780013099 ()

  • LP
14-0020

  • 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
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
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