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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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SAPPHIRE X - 00840606163514

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 26MM
SPINAL ELEMENTS, INC.
27002-026
In Commercial Distribution

  • 00840606163514 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606163507

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 24MM
SPINAL ELEMENTS, INC.
27002-024
In Commercial Distribution

  • 00840606163507 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606163484

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 20MM
SPINAL ELEMENTS, INC.
27002-020
In Commercial Distribution

  • 00840606163484 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606162326

SAPPHIRE X® SINGLE LEVEL INSERTER, EXTERNAL SHAFT, LONG
SPINAL ELEMENTS, INC.
27010-003-01
In Commercial Distribution

  • 00840606162326 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606162302

SAPPHIRE X® SINGLE LEVEL INSERTER, LONG
SPINAL ELEMENTS, INC.
27010-003
In Commercial Distribution

  • 00840606162302 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606161664

SAPPHIRE X® 1-LEVEL PLATE, CADDY, LID
SPINAL ELEMENTS, INC.
27000-000-22
In Commercial Distribution

  • 00840606161664 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161640

SAPPHIRE X® 1-LEVEL PLATE, CADDY ASSEMBLY
SPINAL ELEMENTS, INC.
27000-000-20
In Commercial Distribution

  • 00840606161640 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161626

SAPPHIRE X® VARIABLE ANGLE SCREW, CADDY, BASE
SPINAL ELEMENTS, INC.
27000-000-18
In Commercial Distribution

  • 00840606161626 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161602

16MM X 13MM 7° TI-BOND INTERBODY CAGE, CADDY, LID
SPINAL ELEMENTS, INC.
27000-000-16
In Commercial Distribution

  • 00840606161602 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161596

16MM X 13MM 7° TI-BOND INTERBODY CAGE, CADDY, BASE
SPINAL ELEMENTS, INC.
27000-000-15
In Commercial Distribution

  • 00840606161596 ()


  • Device sterilization/disinfection container, reusable
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