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

  • 00846468022228 ()


  • General internal orthopaedic fixation system implantation kit
THORACIC LAMINAR HOOK, SMALL
Pioneer Surgical Technology, Inc.
10-TLH-S
Not in Commercial Distribution

  • 00846468022211 ()
10-TLH-S

  • Bone-screw internal spinal fixation system, non-sterile
THORACIC LAMINAR HOOK, LARGE
Pioneer Surgical Technology, Inc.
10-TLH-L
Not in Commercial Distribution

  • 00846468022204 ()
10-TLH-L

  • Bone-screw internal spinal fixation system, non-sterile
THORACIC LAMINAR HOOK, ANGLED, RIGHT
Pioneer Surgical Technology, Inc.
10-TLHA-R
Not in Commercial Distribution

  • 00846468022198 ()
10-TLHA-R

  • Bone-screw internal spinal fixation system, non-sterile
DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
10-TLHANDLE
Not in Commercial Distribution

  • 00846468022181 ()


  • General internal orthopaedic fixation system implantation kit
THORACIC LAMINAR HOOK, ANGLED, LEFT
Pioneer Surgical Technology, Inc.
10-TLHA-L
Not in Commercial Distribution

  • 00846468022174 ()
10-TLHA-L

  • Bone-screw internal spinal fixation system, non-sterile
T-HANDLE
Pioneer Surgical Technology, Inc.
10-THANDLE
Not in Commercial Distribution

  • 00846468022150 ()


  • General internal orthopaedic fixation system implantation kit
ROD TEMPLATE
Pioneer Surgical Technology, Inc.
10-TEMPLATE-600
Not in Commercial Distribution

  • 00846468022143 ()


  • General internal orthopaedic fixation system implantation kit
ROD TEMPLATE
Pioneer Surgical Technology, Inc.
10-TEMPLATE-400
Not in Commercial Distribution

  • 00846468022136 ()


  • General internal orthopaedic fixation system implantation kit
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