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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 - 00191083028897

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1445-11-6
Not in Commercial Distribution


  • 14mm (W) x 11mm (H) x 45mm (L) x 6° Lordotic
35-1445-11-6

  • Polymeric spinal interbody fusion cage

Cross-Fuse® PEEK IBF System - 00191083028859

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1440-15
Not in Commercial Distribution


  • 14mm (W) x 15mm (H) x 40mm (L)
35-1440-15

  • Polymeric spinal interbody fusion cage

Streamline TL Spinal Fixation System - 00191083024448

Pedicle Screw, Polyaxial, Cannulated, Reduction
Xtant Medical Holdings, Inc.
01-RS-C-95-45
Not in Commercial Distribution

01-RS-C-95-45

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083024424

Pedicle Screw, Polyaxial, Cannulated, Reduction
Xtant Medical Holdings, Inc.
01-RS-C-95-100
Not in Commercial Distribution

01-RS-C-95-100

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083024417

Pedicle Screw, Polyaxial, Cannulated, Reduction
Xtant Medical Holdings, Inc.
01-RS-C-85-95
Not in Commercial Distribution

01-RS-C-85-95

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083024394

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

01-RS-C-85-85

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083024370

Pedicle Screw, Polyaxial, Cannulated, Reduction
Xtant Medical Holdings, Inc.
01-RS-C-85-75
Not in Commercial Distribution

01-RS-C-85-75

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083024363

Pedicle Screw, Polyaxial, Cannulated, Reduction
Xtant Medical Holdings, Inc.
01-RS-C-85-70
Not in Commercial Distribution

01-RS-C-85-70

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083024356

Pedicle Screw, Polyaxial, Cannulated, Reduction
Xtant Medical Holdings, Inc.
01-RS-C-85-65
Not in Commercial Distribution

01-RS-C-85-65

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083024332

Pedicle Screw, Polyaxial, Cannulated, Reduction
Xtant Medical Holdings, Inc.
01-RS-C-85-55
Not in Commercial Distribution

01-RS-C-85-55

  • Spinal bone screw, non-bioabsorbable
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