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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 - 00846468021092

PEDICLE MARKER
Pioneer Surgical Technology, Inc.
10-MARKER
Not in Commercial Distribution

  • 00846468021092 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021085

ROD REDUCER
Pioneer Surgical Technology, Inc.
10-MANIPULATOR
Not in Commercial Distribution

  • 00846468021085 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021078

ROD REDUCER, ANGLED
Pioneer Surgical Technology, Inc.
10-MANIPANGLED
Not in Commercial Distribution

  • 00846468021078 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021009

LOCKING TUBE
Pioneer Surgical Technology, Inc.
10-LOCKINGTUBE
Not in Commercial Distribution

  • 00846468021009 ()


  • General internal orthopaedic fixation system implantation kit

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468020989

LATERAL OFFSET CONNECTOR
Pioneer Surgical Technology, Inc.
10-LOC-40
Not in Commercial Distribution

  • 00846468020989 ()
10-LOC-40

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468020972

LATERAL OFFSET CONNECTOR
Pioneer Surgical Technology, Inc.
10-LOC-30
Not in Commercial Distribution

  • 00846468020972 ()
10-LOC-30

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468020965

LATERAL OFFSET CONNECTOR
Pioneer Surgical Technology, Inc.
10-LOC-20
Not in Commercial Distribution

  • 00846468020965 ()
10-LOC-20

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468020958

LAMINAR HOOK, LUMBAR, SMALL
Pioneer Surgical Technology, Inc.
10-LLH-S
Not in Commercial Distribution

  • 00846468020958 ()
10-LLH-S

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468020934

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

  • 00846468020934 ()
10-LLH-L

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468020927

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

  • 00846468020927 ()
10-LLHE-S

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