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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 - 00846468002770

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

83-RASP-10

  • Bone file/rasp, manual, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002763

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

83-RASP-08

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002756

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

83-L-INSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002749

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

83-L-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002732

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

83-DRIVER

  • Orthopaedic counter-torque/rod-pushing instrument

Quantum BacFuse Spinous Process Fusion Plate - 00846468002725

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

83-DILATOR-08

  • Nerve/vessel retractor

Quantum BacFuse Spinous Process Fusion Plate - 00846468002718

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

83-DILATOR-05

  • Nerve/vessel retractor

Quantum BacFuse Spinous Process Fusion Plate - 00846468002695

Instrument Case
Pioneer Surgical Technology, Inc.
83-CASE
Not in Commercial Distribution

  • 00846468002695 ()
83-CASE

  • 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 - 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 - 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 - 00846468002701

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

  • 00846468002701 ()
83-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002688

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

83-B-INSERTER

  • General internal orthopaedic fixation system implantation kit

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 - 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 Intersegmental Table, with Patient Assist - 00850020142422

No Description
PIVOTAL HEALTH SOLUTIONS, INC.
Q400P
In Commercial Distribution

  • 00850020142422 ()


  • Traction table, line-powered

Quantum Perfusion Dual Lumen Cannula 24F-V1 - 08051160301768

No Description
SPECTRUM MEDICAL SRL
DL24F-V1
In Commercial Distribution

  • 08051160301768 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

Quantum Perfusion Dual Lumen Cannula 27F-V1 - 08051160301751

No Description
SPECTRUM MEDICAL SRL
DL27F-V1
In Commercial Distribution

  • 08051160301751 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

Quantum Perfusion Dual Lumen Cannula 29F-V1 - 08051160301744

No Description
SPECTRUM MEDICAL SRL
DL29F-V1
In Commercial Distribution

  • 08051160301744 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
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