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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® Spinal Fixation System - 00846468022235

GAGE, X-LINK®, VARIABLE, 30mm-40mm
Pioneer Surgical Technology, Inc.
10-VXLG-3040
Not in Commercial Distribution

  • 00846468022235 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022228

CADDY, X-LINK™, VARIABLE
Pioneer Surgical Technology, Inc.
10-VXLCADDY
Not in Commercial Distribution

  • 00846468022228 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022181

DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
10-TLHANDLE
Not in Commercial Distribution

  • 00846468022181 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022150

T-HANDLE
Pioneer Surgical Technology, Inc.
10-THANDLE
Not in Commercial Distribution

  • 00846468022150 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022143

ROD TEMPLATE
Pioneer Surgical Technology, Inc.
10-TEMPLATE-600
Not in Commercial Distribution

  • 00846468022143 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022136

ROD TEMPLATE
Pioneer Surgical Technology, Inc.
10-TEMPLATE-400
Not in Commercial Distribution

  • 00846468022136 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022129

ROD TEMPLATE
Pioneer Surgical Technology, Inc.
10-TEMPLATE-250
Not in Commercial Distribution

  • 00846468022129 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022112

TAP SLEEVE
Pioneer Surgical Technology, Inc.
10-TAPSLEEVE
Not in Commercial Distribution

  • 00846468022112 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022105

TAP, 7.25mm, EXTENDED LENGTH
Pioneer Surgical Technology, Inc.
10-TAP-725-E
Not in Commercial Distribution

  • 00846468022105 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022099

TAP, 7.25mm, 1" THREAD
Pioneer Surgical Technology, Inc.
10-TAP-725-1
Not in Commercial Distribution

  • 00846468022099 ()


  • General internal orthopaedic fixation system implantation kit
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