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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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1-LEVEL SAPPHIRE X® CERVICAL PLATE, 12MM
SPINAL ELEMENTS, INC.
27001-012
In Commercial Distribution

  • 00840606159944 ()


  • Spinal fixation plate, non-bioabsorbable
1-LEVEL SAPPHIRE X® CERVICAL PLATE, 10MM
SPINAL ELEMENTS, INC.
27001-010
In Commercial Distribution

  • 00840606159920 ()


  • Spinal fixation plate, non-bioabsorbable
1-LEVEL SAPPHIRE X® CERVICAL PLATE, 8MM
SPINAL ELEMENTS, INC.
27001-008
In Commercial Distribution

  • 00840606159906 ()


  • Spinal fixation plate, non-bioabsorbable
2-LEVEL SAPPHIRE X® CERVICAL PLATE, 32MM
SPINAL ELEMENTS, INC.
27002-032
In Commercial Distribution

  • 00840606163545 ()


  • Spinal fixation plate, non-bioabsorbable
2-LEVEL SAPPHIRE X® CERVICAL PLATE, 30MM
SPINAL ELEMENTS, INC.
27002-030
In Commercial Distribution

  • 00840606163538 ()


  • Spinal fixation plate, non-bioabsorbable
2-LEVEL SAPPHIRE X® CERVICAL PLATE, 26MM
SPINAL ELEMENTS, INC.
27002-026
In Commercial Distribution

  • 00840606163514 ()


  • Spinal fixation plate, non-bioabsorbable
2-LEVEL SAPPHIRE X® CERVICAL PLATE, 24MM
SPINAL ELEMENTS, INC.
27002-024
In Commercial Distribution

  • 00840606163507 ()


  • Spinal fixation plate, non-bioabsorbable
2-LEVEL SAPPHIRE X® CERVICAL PLATE, 20MM
SPINAL ELEMENTS, INC.
27002-020
In Commercial Distribution

  • 00840606163484 ()


  • Spinal fixation plate, non-bioabsorbable
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® SINGLE LEVEL INSERTER, LONG
SPINAL ELEMENTS, INC.
27010-003
In Commercial Distribution

  • 00840606162302 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X® 1-LEVEL PLATE, CADDY, LID
SPINAL ELEMENTS, INC.
27000-000-22
In Commercial Distribution

  • 00840606161664 ()


  • Device sterilization/disinfection container, reusable
SAPPHIRE X® 1-LEVEL PLATE, CADDY ASSEMBLY
SPINAL ELEMENTS, INC.
27000-000-20
In Commercial Distribution

  • 00840606161640 ()


  • Device sterilization/disinfection container, reusable
SAPPHIRE X® VARIABLE ANGLE SCREW, CADDY, BASE
SPINAL ELEMENTS, INC.
27000-000-18
In Commercial Distribution

  • 00840606161626 ()


  • Device sterilization/disinfection container, reusable
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
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
16MM X 13MM 7° TI-BOND INTERBODY CAGE, CADDY ASSEMBLY
SPINAL ELEMENTS, INC.
27000-000-14
In Commercial Distribution

  • 00840606161589 ()


  • Device sterilization/disinfection container, reusable
14MM X 11MM 7° TI-BOND INTERBODY CAGE, CADDY, LID
SPINAL ELEMENTS, INC.
27000-000-13
In Commercial Distribution

  • 00840606161572 ()


  • Device sterilization/disinfection container, reusable
14MM X 11MM 7° TI-BOND INTERBODY CAGE, CADDY, BASE
SPINAL ELEMENTS, INC.
27000-000-12
In Commercial Distribution

  • 00840606161565 ()


  • Device sterilization/disinfection container, reusable
14MM X 11MM 7° TI-BOND INTERBODY CAGE, CADDY ASSEMBLY
SPINAL ELEMENTS, INC.
27000-000-11
In Commercial Distribution

  • 00840606161558 ()


  • Device sterilization/disinfection container, reusable
SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, CADDY INSERT
SPINAL ELEMENTS, INC.
27000-000-10
In Commercial Distribution

  • 00840606161541 ()


  • Device sterilization/disinfection container, reusable
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