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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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LAMINAR HOOK EXTENDED, LUMBAR, LARGE
Pioneer Surgical Technology, Inc.
10-LLHE-L
Not in Commercial Distribution

  • 00846468020903 ()
10-LLHE-L

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

  • 00846468020897 ()
10-LHO-R

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

  • 00846468020880 ()
10-LHO-L

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

  • 00846468020873 ()


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

  • 00846468020866 ()
10-LCAP

  • Bone-screw internal spinal fixation system, non-sterile
INSTRUMENT CASE, LUMBAR, SECONDARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-S
Not in Commercial Distribution

  • 00846468020842 ()


  • General internal orthopaedic fixation system implantation kit
INSTRUMENT CASE, LUMBAR, PRIMARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-P
Not in Commercial Distribution

  • 00846468020835 ()


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

  • 00846468020828 ()


  • General internal orthopaedic fixation system implantation kit
IN-SITU ROD BENDER, RIGHT
Pioneer Surgical Technology, Inc.
10-INSITUBEND-R
Not in Commercial Distribution

  • 00846468020811 ()


  • General internal orthopaedic fixation system implantation kit
IN-SITU ROD BENDER, LEFT
Pioneer Surgical Technology, Inc.
10-INSITUBEND-L
Not in Commercial Distribution

  • 00846468020804 ()


  • General internal orthopaedic fixation system implantation kit
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