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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 - 00846468089979

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-775-PA-70
Not in Commercial Distribution


  • 7.75mm (D) X 70mm (L)
10-775-PA-70

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

Quantum Spinal Fixation System - 00846468089962

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-775-PA-65
Not in Commercial Distribution


  • 7.75mm (D) X 65mm (L)
10-775-PA-65

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

Endo Motor - 06970873260259

No Description
DENJOY DENTAL CO.,LTD
Ai Mate-II
In Commercial Distribution

  • 06970873260259 ()


  • Multi-purpose surgical power tool system, line-powered

Endo Motor - 06970873260198

No Description
DENJOY DENTAL CO.,LTD
Ai Mate-I
In Commercial Distribution

  • 06970873260198 ()


  • Multi-purpose surgical power tool system, line-powered

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468050559

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468043339

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468043322

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468043315

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468043308

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468043292

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
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