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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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Biopor® - CSH05540

Sheet 0.45 x 50 x 40 mm
CEREMED, INC.
CSH-0554
In Commercial Distribution

  • CSH05540 ()

  • Length: 40 Millimeter
CSH-0554

  • Polyethylene craniofacial tissue reconstructive material

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240295040

10X40mm SIJ Implant
TENON MEDICAL, INC.
40295-04
Not in Commercial Distribution

  • B74240295040 ()

  • Outer Diameter: 10 Millimeter
  • Length: 40 Millimeter
40295-04

  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) - B74240295020

7.5X40mm SIJ Implant
TENON MEDICAL, INC.
40295-02
Not in Commercial Distribution

  • B74240295020 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 40 Millimeter
40295-02

  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile

Cervical Interbody Spacer - B114201060

6mm Cervical PEEK inter-vertebral body spacer
CALVARY SPINE, LLC
6mm Large 14mm x 18mm
In Commercial Distribution

  • B114201060 ()

  • Height: 6 Millimeter
201-06

  • Polymeric spinal interbody fusion cage

Cervical Interbody Spacer - B114200060

6mm Cervical PEEK inter-vertebral body spacer
CALVARY SPINE, LLC
6mm Standard 11mm x 13mm
In Commercial Distribution

  • B114200060 ()

  • Height: 6 Millimeter
200-06

  • Polymeric spinal interbody fusion cage

TiNano - B5211050000060

DISCOVERY Cervical Interbody Fusion System, 12mm x 14mm x 0 degrees x 6mm
AURORA SPINE, INC.
DISCOVERY
In Commercial Distribution

  • B5211050000060 ()

  • Height: 6 Millimeter
  • Angle: 0 degree
  • Width: 14 Millimeter
  • Length: 12 Millimeter
105-000-006

  • Polymeric spinal fusion cage, sterile

ZIP - B5211030160400

ZIP LP MIS Interspinous Fusion System, 16mm X 40mm
AURORA SPINE, INC.
LP
In Commercial Distribution

  • B5211030160400 ()

  • Length: 40 Millimeter
  • Lumen/Inner Diameter: 16 Millimeter
103-016-040

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

ZIP - B5211030140400

ZIP LP MIS Interspinous Fusion System, 14mm X 40mm
AURORA SPINE, INC.
LP
In Commercial Distribution

  • B5211030140400 ()

  • Length: 40 Millimeter
  • Lumen/Inner Diameter: 14 Millimeter
103-014-040

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

ZIP - B5211030120400

ZIP LP MIS Interspinous Fusion System, 12mm X 40mm
AURORA SPINE, INC.
LP
In Commercial Distribution

  • B5211030120400 ()

  • Length: 40 Millimeter
  • Lumen/Inner Diameter: 12 Millimeter
103-012-040

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

ZIP - B5211030100400

ZIP LP MIS Interspinous Fusion System, 10mm X 40mm
AURORA SPINE, INC.
LP
In Commercial Distribution

  • B5211030100400 ()

  • Length: 40 Millimeter
  • Lumen/Inner Diameter: 10 Millimeter
103-010-040

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
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