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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® II PEEK IBF System - 00191083032559

ANGLED INSERTER
Rti Surgical, Inc.
38-A-INSERTER-26
In Commercial Distribution


  • 26mm
38-A-INSERTER-26

  • Orthopaedic inorganic implant inserter/extractor, reusable

Cross-Fuse® II PEEK IBF System - 00191083032528

ANGLED INSERTER
Rti Surgical, Inc.
38-A-INSERTER-14
In Commercial Distribution


  • 14mm
38-A-INSERTER-14

  • Orthopaedic inorganic implant inserter/extractor, reusable

Cross-Fuse® PEEK IBF System - 00191083032504

INSERTER, MODULAR CLEANING
Pioneer Surgical Technology, Inc.
35-INSERTER2-14-CL
Not in Commercial Distribution


  • 14mm
35-INSERTER2-14-CL

  • Orthopaedic inorganic implant inserter/extractor, reusable

Cross-Fuse® PEEK IBF System - 00191083032481

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL22-15
Not in Commercial Distribution


  • 22mm X 15mm
35-DTRL22-15

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032450

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-9-6
Not in Commercial Distribution


  • 18mm X 9mm, 6 Degrees
35-DTRL18-9-6

  • 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 - 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 - 00191083032375

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-11-6
Not in Commercial Distribution


  • 18mm X 11mm, 6 Degrees
35-DTRL18-11-6

  • 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
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