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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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Cross-Fuse® PEEK IBF System - 00191083032443

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-9
Not in Commercial Distribution


  • 18mm X 9mm
35-DTRL18-9

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032436

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-17-6
Not in Commercial Distribution

  • 00191083032436 ()

  • 18mm X 17mm, 6 Degrees
35-DTRL18-17-6

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032429

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-17
Not in Commercial Distribution


  • 18mm X 17mm
35-DTRL18-17

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032412

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-15-6
Not in Commercial Distribution


  • 18mm X 15mm, 6 Degrees
35-DTRL18-15-6

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032405

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-15
Not in Commercial Distribution


  • 18mm X 15mm
35-DTRL18-15

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032399

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-13-6
Not in Commercial Distribution


  • 18mm X 13mm, 6 Degrees
35-DTRL18-13-6

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032382

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-13
Not in Commercial Distribution


  • 18mm X 13mm
35-DTRL18-13

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032368

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-11
Not in Commercial Distribution


  • 18mm X 11mm
35-DTRL18-11

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032344

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL14-9
Not in Commercial Distribution


  • 14mm X 9mm
35-DTRL14-9

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032313

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL14-15
Not in Commercial Distribution


  • 14mm X 15mm
35-DTRL14-15

  • Surgical implant template, reusable
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