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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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C-Plus PEEK IBF System - 00846468005146

UNI-CORTICAL 14X16X9mm TRIAL
Pioneer Surgical Technology, Inc.
725-175
In Commercial Distribution

  • 00846468005146 ()

  • Height: 9 Millimeter
725-175

  • Surgical implant/trial-implant/sizer holder, reusable

Blustone Synergy Lumbar Trial/Spreader (Basalt, Obsidian, Magma) - 00810482030705

The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The lumbar trials/spreaders are available in sizes between 7mm and 15mm.
BLUSTONE SYNERGY, LLC
9000-SP09
In Commercial Distribution

  • 00810482030705 ()

  • Height: 9 Millimeter


  • Surgical implant template, reusable

Blustone Synergy Lumbar Interbody Fusion System (Obsidian) - 00810482030477

The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via a transforaminal (TLIF) approach.
BLUSTONE SYNERGY, LLC
2811-TL09
In Commercial Distribution

  • 00810482030477 ()

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


  • Polymeric spinal interbody fusion cage

Blustone Synergy Lumbar Interbody Fusion System (Basalt) - 00810482030453

The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in pairs via a posterior (PLIF) approach; or - as a single device via a transverse (T-PLIF) approach.
BLUSTONE SYNERGY, LLC
2410-PP09
In Commercial Distribution

  • 00810482030453 ()

  • Height: 9 Millimeter
  • Width: 10 Millimeter
  • Length: 24 Millimeter


  • Polymeric spinal interbody fusion cage

Blustone Synergy Cervical Trial (Slate) - 00810482031375

The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical trials are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.
BLUSTONE SYNERGY, LLC
9017-CTP09
In Commercial Distribution

  • 00810482031375 ()

  • Width: 13 Millimeter
  • Height: 9 Millimeter
  • Length: 17 Millimeter


  • Surgical implant template, reusable

Blustone Synergy Cervical Trial (Slate) - 00810482031290

The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical trials are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.
BLUSTONE SYNERGY, LLC
9017-CTL09
In Commercial Distribution

  • 00810482031290 ()

  • Width: 13 Millimeter
  • Height: 9 Millimeter
  • Length: 17 Millimeter


  • Surgical implant template, reusable

Blustone Synergy Cervical Trial (Slate) - 00810482031092

The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical trials are available in parallel and lordotic configurations, 14mmX11mm and 17mmX13mm sizes and thicknesses between 5mm and 11mm.
BLUSTONE SYNERGY, LLC
9014-CTP9
In Commercial Distribution

  • 00810482031092 ()

  • Width: 11 Millimeter
  • Length: 14 Millimeter
  • Height: 9 Millimeter


  • Surgical implant template, reusable

Blustone Synergy Cervical Trial (Slate) - 00810482031023

The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical trials are available in parallel and lordotic configurations, 14mmX11mm and 17mmX13mm sizes and thicknesses between 5mm and 11mm.
BLUSTONE SYNERGY, LLC
9014-CTL9
In Commercial Distribution

  • 00810482031023 ()

  • Length: 14 Millimeter
  • Width: 11 Millimeter
  • Height: 9 Millimeter


  • Surgical implant template, reusable

Blustone Synergy Cervical Rasp - 00810482031238

The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical rasps are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.
BLUSTONE SYNERGY, LLC
9017-CRP9
In Commercial Distribution

  • 00810482031238 ()

  • Width: 13 Millimeter
  • Height: 9 Millimeter
  • Length: 17 Millimeter


  • Bone file

Blustone Synergy Cervical Rasp - 00810482031160

The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical rasps are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.
BLUSTONE SYNERGY, LLC
9017-CRL9
In Commercial Distribution

  • 00810482031160 ()

  • Width: 13 Millimeter
  • Height: 9 Millimeter
  • Length: 17 Millimeter


  • Bone file
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