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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
SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, INSTRUMENT INSERT
SPINAL ELEMENTS, INC.
27000-000-09
In Commercial Distribution

  • 00840606161534 ()


  • Device sterilization/disinfection container, reusable
SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, LID
SPINAL ELEMENTS, INC.
27000-000-08
In Commercial Distribution

  • 00840606161527 ()


  • Device sterilization/disinfection container, reusable
SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, BASE
SPINAL ELEMENTS, INC.
27000-000-07
In Commercial Distribution

  • 00840606161510 ()


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

  • 00840606161503 ()


  • Device sterilization/disinfection container, reusable
SAPPHIRE X®, 10MM AWL
SPINAL ELEMENTS, INC.
27034-000
In Commercial Distribution

  • 00840606160414 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X®, AWL-DRILL Ø2.0 X 16MM
SPINAL ELEMENTS, INC.
27033-016
In Commercial Distribution

  • 00840606160391 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X®, AWL-DRILL Ø2.0 X 12MM
SPINAL ELEMENTS, INC.
27033-012
In Commercial Distribution

  • 00840606160377 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X®, DRILL Ø2.0 X 18MM
SPINAL ELEMENTS, INC.
27032-018
In Commercial Distribution

  • 00840606160353 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X®, DRILL Ø2.0 X 14MM
SPINAL ELEMENTS, INC.
27032-014
In Commercial Distribution

  • 00840606160339 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X®, DRILL Ø2.0 X 12MM
SPINAL ELEMENTS, INC.
27032-012
In Commercial Distribution

  • 00840606160322 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X®, DRILL Ø2.0 X 10MM
SPINAL ELEMENTS, INC.
27032-010
In Commercial Distribution

  • 00840606160315 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
1-LEVEL SAPPHIRE X® CERVICAL PLATE, 11MM
SPINAL ELEMENTS, INC.
27001-011
In Commercial Distribution

  • 00840606159937 ()


  • Spinal fixation plate, non-bioabsorbable
1-LEVEL SAPPHIRE X® CERVICAL PLATE, 9MM
SPINAL ELEMENTS, INC.
27001-009
In Commercial Distribution

  • 00840606159913 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
06172
In Commercial Distribution

  • 00888480111450 ()
06172

  • External orthopaedic fixation system, single-use
No Description
Biomet Orthopedics, LLC
05070
In Commercial Distribution

  • 00888480109235 ()
05070

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
03200
In Commercial Distribution

  • 00888480105534 ()
03200

  • Joint prosthesis implantation kit, reusable
No Description
Biomet Orthopedics, LLC
03191
In Commercial Distribution

  • 00888480105459 ()
03191

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
03187
In Commercial Distribution

  • 00888480105398 ()
03187

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
03170
In Commercial Distribution

  • 00888480105275 ()
03170

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
03165
In Commercial Distribution

  • 00888480105251 ()
03165

  • Instrument tray, reusable
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