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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 - 00846468019020

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-475-PA-45
Not in Commercial Distribution

  • 00846468019020 ()
10-475-PA-45

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468019006

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-475-PA-35
Not in Commercial Distribution

  • 00846468019006 ()
10-475-PA-35

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018986

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-475-PA-25
Not in Commercial Distribution

  • 00846468018986 ()
10-475-PA-25

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018955

PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-475-FX-30
Not in Commercial Distribution

  • 00846468018955 ()
10-475-FX-30

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018931

X-LINK™, VARIABLE
Pioneer Surgical Technology, Inc.
10-4050-VXL
Not in Commercial Distribution

  • 00846468018931 ()
10-4050-VXL

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468022211

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468022204

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468022198

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468022174

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468021528

PRE CONTOURED, J-ROD, RIGHT
Pioneer Surgical Technology, Inc.
10-PJC5003080-R
Not in Commercial Distribution

  • 00846468021528 ()
10-PJC5003080-R

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