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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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PAC Plate Anterior Cervical Plate System - 00846468002893

CERVICAL BONE AWL
Pioneer Surgical Technology, Inc.
20-BONEAWL
Not in Commercial Distribution

20-BONEAWL

  • Bone awl, reusable

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 - 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 - 00846468002831

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

83-SLEEVE-10

  • Orthopaedic implantation sleeve, reusable

C-Plus PEEK IBF System - 00846468002817

MODULAR HANDLE
Pioneer Surgical Technology, Inc.
30-C-HANDLE
Not in Commercial Distribution

30-C-HANDLE

  • General internal orthopaedic fixation system implantation kit

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

Quantum BacFuse Spinous Process Fusion Plate - 00846468002787

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

83-RASP-12

  • Bone file/rasp, manual, reusable

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
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