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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X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-28-FXL
Not in Commercial Distribution

  • 00846468018764 ()
10-28-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-26-FXL
Not in Commercial Distribution

  • 00846468018757 ()
10-26-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-24-FXL
Not in Commercial Distribution

  • 00846468018740 ()
10-24-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-22-FXL
Not in Commercial Distribution

  • 00846468018733 ()
10-22-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-20-FXL
Not in Commercial Distribution

  • 00846468018726 ()
10-20-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-18-FXL
Not in Commercial Distribution

  • 00846468018719 ()
10-18-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-17-FXL
Not in Commercial Distribution

  • 00846468018702 ()
10-17-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-16-FXL
Not in Commercial Distribution

  • 00846468018696 ()
10-16-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-15-FXL
Not in Commercial Distribution

  • 00846468018689 ()
10-15-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-14-FXL
Not in Commercial Distribution

  • 00846468018672 ()
10-14-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-13-FXL
Not in Commercial Distribution

  • 00846468018665 ()
10-13-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-12-FXL
Not in Commercial Distribution

  • 00846468018658 ()
10-12-FXL

  • Bone-screw internal spinal fixation system, non-sterile
X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-11-FXL
Not in Commercial Distribution

  • 00846468018641 ()
10-11-FXL

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

  • 00846468022334 ()


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

  • 00846468022310 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER, X-LINK®
Pioneer Surgical Technology, Inc.
10-XLINKDRIVER
Not in Commercial Distribution

  • 00846468022297 ()


  • General internal orthopaedic fixation system implantation kit
CASE, X-LINK™
Pioneer Surgical Technology, Inc.
10-XLCASE
Not in Commercial Distribution

  • 00846468022280 ()


  • General internal orthopaedic fixation system implantation kit
GAGE, X-LINK®, VARIABLE, 60mm-80mm
Pioneer Surgical Technology, Inc.
10-VXLG-6080
Not in Commercial Distribution

  • 00846468022259 ()


  • General internal orthopaedic fixation system implantation kit
GAGE, X-LINK®, VARIABLE, 40mm-60mm
Pioneer Surgical Technology, Inc.
10-VXLG-4060
Not in Commercial Distribution

  • 00846468022242 ()


  • 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
STABILIZING TUBE
Pioneer Surgical Technology, Inc.
10-STABTUBE
Not in Commercial Distribution

  • 00846468021955 ()


  • General internal orthopaedic fixation system implantation kit
PEDICLE FINDER, STRAIGHT, SMALL, SQUARE TIP
Pioneer Surgical Technology, Inc.
10-SFINDER-SM-S
Not in Commercial Distribution

  • 00846468021900 ()


  • General internal orthopaedic fixation system implantation kit
INSTRUMENT CASE
Pioneer Surgical Technology, Inc.
10-LS-QSRS-CN
Not in Commercial Distribution

  • 00846468074852 ()


  • General internal orthopaedic fixation system implantation kit
ROD, HEX END
Pioneer Surgical Technology, Inc.
10-55-RH-600
Not in Commercial Distribution

  • 00846468050559 ()
10-55-RH-600

  • Bone-screw internal spinal fixation system, non-sterile
CANNULATED SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
51-775-PA-55
Not in Commercial Distribution

  • 00846468043339 ()
51-775-PA-55

  • Bone-screw internal spinal fixation system, non-sterile
CANNULATED SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
51-775-PA-50
Not in Commercial Distribution

  • 00846468043322 ()
51-775-PA-50

  • Bone-screw internal spinal fixation system, non-sterile
CANNULATED SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
51-775-PA-45
Not in Commercial Distribution

  • 00846468043315 ()
51-775-PA-45

  • Bone-screw internal spinal fixation system, non-sterile
CANNULATED SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
51-775-PA-40
Not in Commercial Distribution

  • 00846468043308 ()
51-775-PA-40

  • Bone-screw internal spinal fixation system, non-sterile
CANNULATED SCREW, FIXED
Pioneer Surgical Technology, Inc.
51-775-PA-35
Not in Commercial Distribution

  • 00846468043292 ()
51-775-PA-35

  • Bone-screw internal spinal fixation system, non-sterile
CANNULATED SCREW, FIXED
Pioneer Surgical Technology, Inc.
51-775-PA-30
Not in Commercial Distribution

  • 00846468043285 ()
51-775-PA-30

  • Bone-screw internal spinal fixation system, non-sterile
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