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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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Silverstone Titanium Interbody Fusion System - B417ST02806T1

0degree TLIF Titanium Silverstone-T
Altus Spine, LLC
ST02806T
In Commercial Distribution

  • B417ST02806T1 ()
  • 00843210107776 ()

  • Width: 10 Millimeter
  • Length: 28 Millimeter
  • Height: 6 Millimeter


  • Metallic spinal fusion cage, non-sterile

Silverstone Interbody Fusion System - B417SEC00928141

9mm x 28mm x 14mm 0degree PEEK Silverstone - EC
Altus Spine, LLC
SEC00928-14
In Commercial Distribution

  • B417SEC00928141 ()
  • 00843210102511 ()

  • Height: 14 Millimeter
  • Length: 28 Millimeter
  • Width: 9 Millimeter


  • Polymeric spinal interbody fusion cage

Silverstone Interbody Fusion System - B417SEC00928121

9mm x 28mm x 12mm 0degree PEEK Silverstone - EC
Altus Spine, LLC
SEC00928-12
In Commercial Distribution

  • B417SEC00928121 ()
  • 00843210102498 ()

  • Height: 12 Millimeter
  • Width: 9 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal interbody fusion cage

Silverstone Interbody Fusion System - B417SEC00928101

9mm x 28mm x 10mm 0degree PEEK Silverstone - EC
Altus Spine, LLC
SEC00928-10
In Commercial Distribution

  • B417SEC00928101 ()
  • 00843210102474 ()

  • Length: 28 Millimeter
  • Height: 10 Millimeter
  • Width: 9 Millimeter


  • Polymeric spinal interbody fusion cage

Silverstone Interbody Fusion System - B417SEC00928091

9mm x 28mm x 9mm 0degree PEEK Silverstone - EC
Altus Spine, LLC
SEC00928-09
In Commercial Distribution

  • B417SEC00928091 ()
  • 00843210102467 ()

  • Width: 9 Millimeter
  • Length: 28 Millimeter
  • Height: 9 Millimeter


  • Polymeric spinal interbody fusion cage

Silverstone Interbody Fusion System - B417SEC00928151

9mm x 28mm x 15mm 0degree PEEK Silverstone - EC
Altus Spine, LLC
SEC00928-15
In Commercial Distribution

  • B417SEC00928151 ()
  • 00843210102528 ()

  • Width: 9 Millimeter
  • Length: 28 Millimeter
  • Height: 15 Millimeter


  • Polymeric spinal interbody fusion cage

Silverstone Interbody Fusion System - B417SEC00928111

9mm x 28mm x 11mm 0degree PEEK Silverstone - EC
Altus Spine, LLC
SEC00928-11
In Commercial Distribution

  • B417SEC00928111 ()
  • 00843210102481 ()

  • Length: 28 Millimeter
  • Height: 11 Millimeter
  • Width: 9 Millimeter


  • Polymeric spinal interbody fusion cage

Fuji Cervical Plate System - B41711401281

28mm Level 1 Cervical Plate System - Fuji
Altus Spine, LLC
114-0128
In Commercial Distribution

  • B41711401281 ()
  • 00843210102931 ()

  • Length: 28 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Bilateral Conformer 22 Regular With Holes - 10697660001064

Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-094T
In Commercial Distribution


  • Length: 28 Millimeter
  • Width: 23 Millimeter
  • Depth: 1.8 Millimeter


  • Ophthalmic conformer

Bilateral Conformer 22 Regular - 10697660001057

Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-094
In Commercial Distribution


  • Length: 28 Millimeter
  • Width: 23 Nanometer
  • Depth: 1.8 Millimeter


  • Ophthalmic conformer
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