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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 - 00846468047900

10mm Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-10
Not in Commercial Distribution

  • 00846468047900 ()
83-SLEEVE-10

  • Orthopaedic implantation sleeve, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047894

8mm Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-08
Not in Commercial Distribution

  • 00846468047894 ()
83-SLEEVE-08

  • Orthopaedic implantation sleeve, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047870

16mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-16
Not in Commercial Distribution

  • 00846468047870 ()
83-RASP-16

  • Bone file/rasp, manual, reusable

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

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468041809

MIDDLE TRAY
Pioneer Surgical Technology, Inc.
430-161
Not in Commercial Distribution

  • 00846468041809 ()
430-161

  • Device sterilization/disinfection container, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468041793

TOP TRAY
Pioneer Surgical Technology, Inc.
430-160
Not in Commercial Distribution

  • 00846468041793 ()
430-160

  • Device sterilization/disinfection container, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047863

14mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-14
Not in Commercial Distribution

  • 00846468047863 ()
83-RASP-14

  • Bone file/rasp, manual, reusable

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
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