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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 - 00840606159944

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

  • 00840606159944 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159920

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 10MM
SPINAL ELEMENTS, INC.
27001-010
In Commercial Distribution

  • 00840606159920 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159906

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 8MM
SPINAL ELEMENTS, INC.
27001-008
In Commercial Distribution

  • 00840606159906 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606163545

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 32MM
SPINAL ELEMENTS, INC.
27002-032
In Commercial Distribution

  • 00840606163545 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606163538

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 30MM
SPINAL ELEMENTS, INC.
27002-030
In Commercial Distribution

  • 00840606163538 ()


  • Spinal fixation plate, non-bioabsorbable

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

SAPPHIRE X - 00840606161589

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

SAPPHIRE X - 00840606161572

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

SAPPHIRE X - 00840606161565

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

SAPPHIRE X - 00840606161558

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 - 00840606161541

SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, CADDY INSERT
SPINAL ELEMENTS, INC.
27000-000-10
In Commercial Distribution

  • 00840606161541 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161534

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

  • 00840606161534 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161527

SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, LID
SPINAL ELEMENTS, INC.
27000-000-08
In Commercial Distribution

  • 00840606161527 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161510

SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, BASE
SPINAL ELEMENTS, INC.
27000-000-07
In Commercial Distribution

  • 00840606161510 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161503

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

  • 00840606161503 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606160414

SAPPHIRE X®, 10MM AWL
SPINAL ELEMENTS, INC.
27034-000
In Commercial Distribution

  • 00840606160414 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160391

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 - 00840606160377

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 - 00840606160353

SAPPHIRE X®, DRILL Ø2.0 X 18MM
SPINAL ELEMENTS, INC.
27032-018
In Commercial Distribution

  • 00840606160353 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160339

SAPPHIRE X®, DRILL Ø2.0 X 14MM
SPINAL ELEMENTS, INC.
27032-014
In Commercial Distribution

  • 00840606160339 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160322

SAPPHIRE X®, DRILL Ø2.0 X 12MM
SPINAL ELEMENTS, INC.
27032-012
In Commercial Distribution

  • 00840606160322 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160315

SAPPHIRE X®, DRILL Ø2.0 X 10MM
SPINAL ELEMENTS, INC.
27032-010
In Commercial Distribution

  • 00840606160315 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606159937

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 11MM
SPINAL ELEMENTS, INC.
27001-011
In Commercial Distribution

  • 00840606159937 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159913

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 9MM
SPINAL ELEMENTS, INC.
27001-009
In Commercial Distribution

  • 00840606159913 ()


  • Spinal fixation plate, non-bioabsorbable

X FIX - 00888480111450

No Description
Biomet Orthopedics, LLC
06172
In Commercial Distribution

  • 00888480111450 ()
06172

  • External orthopaedic fixation system, single-use

X FIX - 00888480109235

No Description
Biomet Orthopedics, LLC
05070
In Commercial Distribution

  • 00888480109235 ()
05070

  • Instrument tray, reusable

X FIX - 00888480105534

No Description
Biomet Orthopedics, LLC
03200
In Commercial Distribution

  • 00888480105534 ()
03200

  • Joint prosthesis implantation kit, reusable

X FIX - 00888480105459

No Description
Biomet Orthopedics, LLC
03191
In Commercial Distribution

  • 00888480105459 ()
03191

  • Instrument tray, reusable

X FIX - 00888480105398

No Description
Biomet Orthopedics, LLC
03187
In Commercial Distribution

  • 00888480105398 ()
03187

  • Instrument tray, reusable

X FIX - 00888480105275

No Description
Biomet Orthopedics, LLC
03170
In Commercial Distribution

  • 00888480105275 ()
03170

  • Instrument tray, reusable

X FIX - 00888480105251

No Description
Biomet Orthopedics, LLC
03165
In Commercial Distribution

  • 00888480105251 ()
03165

  • Instrument tray, reusable
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