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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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Unison™-C Anterior Cervical Fixation System - 00846468076900

Angled Driver Handle
Pioneer Surgical Technology, Inc.
63-ANG-HOUSING
Not in Commercial Distribution

  • 00846468076900 ()


  • General internal orthopaedic fixation system implantation kit

Unison™-C Anterior Cervical Fixation System - 00846468076870

Screw Driver
Pioneer Surgical Technology, Inc.
63-SCREWDRIVER
Not in Commercial Distribution

  • 00846468076870 ()


  • General internal orthopaedic fixation system implantation kit

ASPECT®Anterior Cervical Plate System - 00846468053000

SCREW DRIVER
Pioneer Surgical Technology, Inc.
27-DRIVER
Not in Commercial Distribution

  • 00846468053000 ()


  • General internal orthopaedic fixation system implantation kit

ASPECT®Anterior Cervical Plate System - 00846468051631

PIN DRIVER
Pioneer Surgical Technology, Inc.
27-PIN-DRIVER
Not in Commercial Distribution

  • 00846468051631 ()


  • General internal orthopaedic fixation system implantation kit

Elemax® PLIF - 00846468066505

Inserter Fork, Large
Pioneer Surgical Technology, Inc.
32-EL-INSRTFORK-LG
Not in Commercial Distribution

  • 00846468066505 ()


  • General internal orthopaedic fixation system implantation kit

Elemax® PLIF - 00846468066499

Inserter Fork, Medium
Pioneer Surgical Technology, Inc.
32-EL-INSRTFORK-MD
Not in Commercial Distribution

  • 00846468066499 ()


  • General internal orthopaedic fixation system implantation kit

Elemax® PLIF - 00846468066482

Inserter Fork, Small
Pioneer Surgical Technology, Inc.
32-EL-INSRTFORK, SM
Not in Commercial Distribution

  • 00846468066482 ()


  • General internal orthopaedic fixation system implantation kit

Elemax® PLIF - 00846468066475

Inserter
Pioneer Surgical Technology, Inc.
32-EL-INSERTER
Not in Commercial Distribution

  • 00846468066475 ()


  • General internal orthopaedic fixation system implantation kit

Elemax® Cortical Cancellous Spacer - 00846468062712

Inserter Shaft with Stop
Pioneer Surgical Technology, Inc.
30-CC-INSRTSHAFT-S
Not in Commercial Distribution

  • 00846468062712 ()


  • General internal orthopaedic fixation system implantation kit

Elemax® Cortical Cancellous Spacer - 00846468062705

Inserter Shaft
Pioneer Surgical Technology, Inc.
30-CC-INSRTSHAFT
Not in Commercial Distribution

  • 00846468062705 ()


  • General internal orthopaedic fixation system implantation kit
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