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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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Valencia Pedicle Screw System - B41792275551

7.5mm x 55mm Multiaxial Self Tapping Pedicle Screw
Altus Spine, LLC
922-7555
In Commercial Distribution

  • B41792275551 ()
  • 00843210110912 ()

  • Length: 55 Millimeter
  • Outer Diameter: 7.5 Millimeter


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

Valencia Pedicle Screw System - B41791350551

5.5mm x 55mm Straight Rod
Altus Spine, LLC
913-5055
In Commercial Distribution

  • B41791350551 ()
  • 00843210110448 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter


  • Orthopaedic instrument surgical connector

Imola Interbody Fusion System - B417F01855141

14mm, 0degree Lateral Interbody Fusion, 18x55mm, PEEK Implant Assembly
Altus Spine, LLC
F01855-14
In Commercial Distribution

  • B417F01855141 ()
  • 00843210100227 ()

  • Length: 55 Millimeter
  • Width: 18 Millimeter
  • Height: 14 Millimeter


  • Polymeric spinal interbody fusion cage

Imola Titanium Interbody Fusion System - B417F0185512T1

0degree Lateral Interbody Fusion, Titanium Imola - L
Altus Spine, LLC
F01855-12T
In Commercial Distribution

  • B417F0185512T1 ()
  • 00843210104409 ()

  • Height: 12 Millimeter
  • Length: 55 Millimeter
  • Width: 18 Millimeter


  • Metallic spinal fusion cage, non-sterile

Imola Interbody Fusion System - B417F01855121

12mm, 0degree Lateral Interbody Fusion, 18x55mm, PEEK Implant Assembly
Altus Spine, LLC
F01855-12
In Commercial Distribution

  • B417F01855121 ()
  • 00843210100210 ()

  • Height: 12 Millimeter
  • Length: 55 Millimeter
  • Width: 18 Millimeter


  • Polymeric spinal interbody fusion cage

Imola Titanium Interbody Fusion System - B417F0185510T1

0degree Lateral Interbody Fusion, Titanium Imola - L
Altus Spine, LLC
F01855-10T
In Commercial Distribution

  • B417F0185510T1 ()
  • 00843210104393 ()

  • Length: 55 Millimeter
  • Height: 10 Millimeter
  • Width: 18 Millimeter


  • Metallic spinal fusion cage, non-sterile

Imola Interbody Fusion System - B417F01855101

10mm, 0degree Lateral Interbody Fusion, 18x55mm, PEEK Implant Assembly
Altus Spine, LLC
F01855-10
In Commercial Distribution

  • B417F01855101 ()
  • 00843210100203 ()

  • Width: 18 Millimeter
  • Length: 55 Millimeter
  • Height: 10 Millimeter


  • Polymeric spinal interbody fusion cage

Imola Titanium Interbody Fusion System - B417F0185508T1

0degree Lateral Interbody Fusion, Titanium Imola - L
Altus Spine, LLC
F01855-08T
In Commercial Distribution

  • B417F0185508T1 ()
  • 00843210104386 ()

  • Height: 8 Millimeter
  • Length: 55 Millimeter
  • Width: 18 Millimeter


  • Metallic spinal fusion cage, non-sterile

Imola Interbody Fusion System - B417F01855081

8mm, 0degree Lateral Interbody Fusion, 18x55mm, PEEK Implant Assembly
Altus Spine, LLC
F01855-08
In Commercial Distribution

  • B417F01855081 ()
  • 00843210100197 ()

  • Height: 8 Millimeter
  • Width: 18 Millimeter
  • Length: 55 Millimeter


  • Polymeric spinal interbody fusion cage

Valencia Pedicle Screw System - B41799385551

8.5mm x 55mm Triple Lead Closed Head Screw
Altus Spine, LLC
993-8555
In Commercial Distribution

  • B41799385551 ()
  • 00843210117829 ()

  • Length: 55 Millimeter
  • Outer Diameter: 8.5 Millimeter


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