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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 - 00191083032542

ANGLED INSERTER
Rti Surgical, Inc.
38-A-INSERTER-22
In Commercial Distribution


  • 22mm
38-A-INSERTER-22

  • Orthopaedic inorganic implant inserter/extractor, reusable

Cross-Fuse® II PEEK IBF System - 00191083032535

ANGLED INSERTER
Rti Surgical, Inc.
38-A-INSERTER-18
In Commercial Distribution


  • 18mm
38-A-INSERTER-18

  • 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 - 00191083032511

INSERTER, MODULAR CLEANING
Pioneer Surgical Technology, Inc.
35-INSERTER2-18-CL
Not in Commercial Distribution


  • 18mm
35-INSERTER2-18-CL

  • 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 - 00191083032498

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL22-9
Not in Commercial Distribution


  • 22mm X 9mm
35-DTRL22-9

  • Surgical implant template, 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 - 00191083032474

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL22-13
Not in Commercial Distribution


  • 22mm X 13mm
35-DTRL22-13

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032467

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL22-11
Not in Commercial Distribution


  • 22mm X 11mm
35-DTRL22-11

  • 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
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