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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 - 00191083029214

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1845-13-6
Not in Commercial Distribution


  • 18mm (W) x 13mm (H) x 45mm (L) x 6° Lordotic
35-1845-13-6

  • Polymeric spinal interbody fusion cage

Cross-Fuse® PEEK IBF System - 00191083029207

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1845-13
Not in Commercial Distribution


  • 18mm (W) x 13mm (H) x 45mm (L)
35-1845-13

  • Polymeric spinal interbody fusion cage

Cross-Fuse® PEEK IBF System - 00191083029191

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1845-11-6
Not in Commercial Distribution


  • 18mm (W) x 11mm (H) x 45mm (L) x 6° Lordotic
35-1845-11-6

  • Polymeric spinal interbody fusion cage

Cross-Fuse® PEEK IBF System - 00191083029184

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1845-11
Not in Commercial Distribution


  • 18mm (W) x 11mm (H) x 45mm (L)
35-1845-11

  • Polymeric spinal interbody fusion cage

Cross-Fuse® PEEK IBF System - 00191083029177

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1840-9
Not in Commercial Distribution


  • 18mm (W) x 9mm (H) x 40mm (L)
35-1840-9

  • Polymeric spinal interbody fusion cage

Cross-Fuse® PEEK IBF System - 00191083029153

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1840-13
Not in Commercial Distribution


  • 18mm (W) x 13mm (H) x 40mm (L)
35-1840-13

  • Polymeric spinal interbody fusion cage

Cross-Fuse® PEEK IBF System - 00191083029146

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1840-11
Not in Commercial Distribution


  • 18mm (W) x 11mm (H) x 40mm (L)
35-1840-11

  • Polymeric spinal interbody fusion cage

Cross-Fuse® PEEK IBF System - 00191083029139

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1455-9-6
Not in Commercial Distribution


  • 14mm (W) x 9mm (H) x 55mm (L) x 6° Lordotic
35-1455-9-6

  • Polymeric spinal interbody fusion cage

Streamline TL Spinal Fixation System - 00191083024301

Pedicle Screw, Polyaxial, Cannulated, Reduction
Xtant Medical Holdings, Inc.
01-RS-C-85-40
Not in Commercial Distribution

01-RS-C-85-40

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083024288

Pedicle Screw, Polyaxial, Cannulated, Reduction
Xtant Medical Holdings, Inc.
01-RS-C-85-30
Not in Commercial Distribution

01-RS-C-85-30

  • Spinal bone screw, non-bioabsorbable
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