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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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T-Plus PEEK IBF System - 00846468007416

SLAP HAMMER
Pioneer Surgical Technology, Inc.
30-T-SLAPHAMMER
Not in Commercial Distribution

30-T-SLAPHAMMER

  • General internal orthopaedic fixation system implantation kit

T-Plus PEEK IBF System - 00846468007287

INSERTER
Pioneer Surgical Technology, Inc.
30-T-INSERTER
Not in Commercial Distribution

30-T-INSERTER

  • Orthopaedic inorganic implant inserter/extractor, reusable

BULLET-TIP PEEK IBF SYSTEM - 00846468011154

26MM, Lordotic Detachable Trial Caddy
Pioneer Surgical Technology, Inc.
32-CADDY-26-6L
Not in Commercial Distribution

32-CADDY-26-6L

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468011147

26mm, TRIAL CADDY
Pioneer Surgical Technology, Inc.
32-CADDY-26-2
Not in Commercial Distribution

32-CADDY-26-2

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468011130

TRIAL CADDY, 26mm
Pioneer Surgical Technology, Inc.
32-CADDY-26
Not in Commercial Distribution

32-CADDY-26

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468011123

22mm, Lordotic Detachable Trial Caddy
Pioneer Surgical Technology, Inc.
32-CADDY-22-6L
Not in Commercial Distribution

32-CADDY-22-6L

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468011116

22mm, TRIAL CADDY
Pioneer Surgical Technology, Inc.
32-CADDY-22-2
Not in Commercial Distribution

32-CADDY-22-2

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468011109

TRIAL CADDY, 22mm
Pioneer Surgical Technology, Inc.
32-CADDY-22
Not in Commercial Distribution

32-CADDY-22

  • General internal orthopaedic fixation system implantation kit

T-Plus PEEK IBF System - 00846468009052

TRIAL SPACER
Pioneer Surgical Technology, Inc.
30-T-TRL-14-6
Not in Commercial Distribution

30-T-TRL-14-6

  • General internal orthopaedic fixation system implantation kit

T-Plus PEEK IBF System - 00846468008406

TRIAL SPACER
Pioneer Surgical Technology, Inc.
30-T-TRL-10-6
Not in Commercial Distribution

30-T-TRL-10-6

  • General internal orthopaedic fixation system implantation kit
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