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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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Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-10
Not in Commercial Distribution

83-00-10

  • Spinal fixation plate, non-bioabsorbable
Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-08
Not in Commercial Distribution

83-00-08

  • Spinal fixation plate, non-bioabsorbable
No Description
PIVOTAL HEALTH SOLUTIONS, INC.
Q400P
In Commercial Distribution

  • 00850020142422 ()


  • Traction table, line-powered
BACFUSE,INLINE TORQUE LIMITING HANDLE,UL
Pioneer Surgical Technology, Inc.
725-016
Not in Commercial Distribution

  • 00846468000516 ()

  • 30in-lbs (Torque)
725-016

  • General internal orthopaedic fixation system implantation kit
Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-12
Not in Commercial Distribution

83-SLEEVE-12

  • Orthopaedic implantation sleeve, reusable
Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-10
Not in Commercial Distribution

83-SLEEVE-10

  • Orthopaedic implantation sleeve, reusable
Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-08
Not in Commercial Distribution

83-SLEEVE-08

  • Orthopaedic implantation sleeve, reusable
Rasp
Pioneer Surgical Technology, Inc.
83-RASP-16
Not in Commercial Distribution

83-RASP-16

  • Bone file/rasp, manual, reusable
Rasp
Pioneer Surgical Technology, Inc.
83-RASP-14
Not in Commercial Distribution

83-RASP-14

  • Bone file/rasp, manual, reusable
Rasp
Pioneer Surgical Technology, Inc.
83-RASP-12
Not in Commercial Distribution

83-RASP-12

  • Bone file/rasp, manual, reusable
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