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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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Calix Spinal Implant System - M697X03412311

36mm x 24mm x 10mm ALIF BOX BROACH
Xtant Medical Holdings, Inc.
X034-1231
In Commercial Distribution

  • M697X03412310 ()
  • M697X03412311 ()

  • Width: 24 Millimeter
  • Length: 36 Millimeter
  • Height: 10 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03412301

36mm x 24mm x 8mm ALIF BOX BROACH
Xtant Medical Holdings, Inc.
X034-1230
In Commercial Distribution

  • M697X03412300 ()
  • M697X03412301 ()

  • Height: 8 Millimeter
  • Length: 36 Millimeter
  • Width: 24 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 Lumbar Interbody Fusion System (Basalt) - 00810482030446

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-PP08
In Commercial Distribution

  • 00810482030446 ()

  • Height: 8 Millimeter
  • Width: 10 Millimeter
  • Length: 24 Millimeter


  • Polymeric spinal interbody fusion cage

Blustone Synergy Lumbar Interbody Fusion System (Basalt) - 00810482030439

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-PP07
In Commercial Distribution

  • 00810482030439 ()

  • Height: 7 Millimeter
  • Width: 10 Millimeter
  • Length: 24 Millimeter


  • Polymeric spinal interbody fusion cage

Blustone Synergy Lumbar Interbody Fusion System (Basalt) - 00810482030422

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-PL15
In Commercial Distribution

  • 00810482030422 ()

  • Height: 15 Millimeter
  • Width: 10 Millimeter
  • Length: 24 Millimeter


  • Polymeric spinal interbody fusion cage

Blustone Synergy Lumbar Interbody Fusion System (Basalt) - 00810482030415

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-PL14
In Commercial Distribution

  • 00810482030415 ()

  • Height: 14 Millimeter
  • Width: 10 Millimeter
  • Length: 24 Millimeter


  • Polymeric spinal interbody fusion cage

Blustone Synergy Lumbar Interbody Fusion System (Basalt) - 00810482030408

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-PL13
In Commercial Distribution

  • 00810482030408 ()

  • Height: 13 Millimeter
  • Width: 10 Millimeter
  • Length: 24 Millimeter


  • Polymeric spinal interbody fusion cage

Blustone Synergy Lumbar Interbody Fusion System (Basalt) - 00810482030392

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-PL12
In Commercial Distribution

  • 00810482030392 ()

  • Length: 24 Millimeter
  • Height: 12 Millimeter
  • Width: 10 Millimeter


  • Polymeric spinal interbody fusion cage

Blustone Synergy Lumbar Interbody Fusion System (Basalt) - 00810482030385

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-PL11
In Commercial Distribution

  • 00810482030385 ()

  • Width: 10 Millimeter
  • Length: 24 Millimeter
  • Height: 11 Millimeter


  • Polymeric spinal interbody fusion cage
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