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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 - 00846468092009

Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-16
Not in Commercial Distribution

83-00-16

  • Spinal fixation plate, non-bioabsorbable

Quantum BacFuse Spinous Process Fusion Plate - 00846468091989

Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-12
Not in Commercial Distribution

83-00-12

  • Spinal fixation plate, non-bioabsorbable

Quantum BacFuse Spinous Process Fusion Plate - 00846468091996

Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-14
Not in Commercial Distribution

83-00-14

  • Spinal fixation plate, non-bioabsorbable

Quantum BacFuse Spinous Process Fusion Plate - 00846468091972

Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-10
Not in Commercial Distribution

83-00-10

  • Spinal fixation plate, non-bioabsorbable

Quantum BacFuse Spinous Process Fusion Plate - 00846468091965

Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-08
Not in Commercial Distribution

83-00-08

  • Spinal fixation plate, non-bioabsorbable

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
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