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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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Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047856

12mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-12
Not in Commercial Distribution

  • 00846468047856 ()
83-RASP-12

  • Bone file/rasp, manual, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047849

10mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-10
Not in Commercial Distribution

  • 00846468047849 ()
83-RASP-10

  • Bone file/rasp, manual, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047832

8mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-08
Not in Commercial Distribution

  • 00846468047832 ()
83-RASP-08

  • Bone file/rasp, manual, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047825

Lock Plate Inserter
Pioneer Surgical Technology, Inc.
83-L-INSERTER
Not in Commercial Distribution

  • 00846468047825 ()
83-L-INSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047818

Compressor
Pioneer Surgical Technology, Inc.
83-L-COMPRESSOR
Not in Commercial Distribution

  • 00846468047818 ()
83-L-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047801

Driver
Pioneer Surgical Technology, Inc.
83-DRIVER
Not in Commercial Distribution

  • 00846468047801 ()
83-DRIVER

  • Orthopaedic counter-torque/rod-pushing instrument

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047795

8mm Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-08
Not in Commercial Distribution

  • 00846468047795 ()
83-DILATOR-08

  • Nerve/vessel retractor

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047788

5mm Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-05
Not in Commercial Distribution

  • 00846468047788 ()
83-DILATOR-05

  • Nerve/vessel retractor

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047757

Barrel Plate Inserter
Pioneer Surgical Technology, Inc.
83-B-INSERTER
Not in Commercial Distribution

  • 00846468047757 ()
83-B-INSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468041816

BOTTOM TRAY
Pioneer Surgical Technology, Inc.
430-162
Not in Commercial Distribution

  • 00846468041816 ()
430-162

  • Device sterilization/disinfection container, reusable
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