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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 - 00846468000516

BACFUSE,INLINE TORQUE LIMITING HANDLE,UL
Pioneer Surgical Technology, Inc.
725-016
Not in Commercial Distribution

  • 00846468000516 ()

  • 30in-lbs (Torque)
725-016

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002886

Torque Limiting Handle
Pioneer Surgical Technology, Inc.
83-TORQHANDLE
Not in Commercial Distribution

83-TORQHANDLE

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002879

90° Sizing Distractor
Pioneer Surgical Technology, Inc.
83-THINSIZER-90
Not in Commercial Distribution

83-THINSIZER-90

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002862

Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-16
Not in Commercial Distribution

83-SLEEVE-16

  • Orthopaedic implantation sleeve, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002855

Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-14
Not in Commercial Distribution

83-SLEEVE-14

  • Orthopaedic implantation sleeve, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002848

Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-12
Not in Commercial Distribution

83-SLEEVE-12

  • Orthopaedic implantation sleeve, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002831

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

83-SLEEVE-10

  • Orthopaedic implantation sleeve, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002824

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

83-SLEEVE-08

  • Orthopaedic implantation sleeve, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002800

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

83-RASP-16

  • Bone file/rasp, manual, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002794

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

83-RASP-14

  • Bone file/rasp, manual, reusable
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