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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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CREO DLX Threaded Locking Cap Driver
GLOBUS MEDICAL, INC.
6156.5000
In Commercial Distribution

  • 00889095815689 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Lateral Lumbar Interbody Fusion Device Instruments, Spare Case: Sagittae Trial, Sagittae Independent Driver, Slap Hammer, Sagittae Torque Limiting Handle
SPINEEX, INC.
076-030-00
In Commercial Distribution

  • 00819837021146 ()
076-030-00

  • Instrument tray, reusable
Sagittae Independent Driver, SHORT, 440B SST
SPINEEX, INC.
502-030-23
In Commercial Distribution

  • 00819837020941 ()
502-030-23

  • Orthopaedic implant driver
Sagittae Independent Driver, LONG, 440B SST
SPINEEX, INC.
502-030-13
In Commercial Distribution

  • 00819837020781 ()
502-030-13

  • Orthopaedic implant driver
Sagittae Independent Driver, LONG, 465 SST
SPINEEX, INC.
502-030-16
In Commercial Distribution

  • 00819837020545 ()
502-030-16

  • Orthopaedic implant driver
Naked-Driver, 440C SST
SPINEEX, INC.
502-030-14
In Commercial Distribution

  • 00819837020507 ()
502-030-14

  • Orthopaedic implant driver
THE MET ONE CZAR ANTERIOR CERVICAL PLATE SYSTEM IS INTENDED FOR ANTERIOR INTERBODY SCREW FIXATION OF THE CERVICAL SPINE. THE SYSTEM INCLUDES SCREWS, PLATES, AND A SET OF INSTRUMENTS TO INSERT THE IMPLANTS. PLATES ARE AVAILABLE IN A VARIETY OF LENGTHS TO ACCOMODATE FUSION PROCEDURES FROM ONE TO FOUR LEVELS OF THE CERVICAL SPINE. FIXATION IS ACHIEVED BY INSERTING THE SCREWS THROUGH THE OPENINGS IN THE PLATE INTO VERTEBRAL BODIES OF THE CERVICAL SPINE. THE PLATES ARE MANUFACTURED FROM TITANIUM 6 A1-4V ELI PER ASTM F136 AND INVIBIO PEEK-OPTIMA LT1 PER ASTM F2026.
MET 1 TECHNOLOGIES, LLC
66000008
In Commercial Distribution

  • 00819824025034 ()
66000008

  • Spinal fixation plate, non-bioabsorbable
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
MET 1 TECHNOLOGIES, LLC
30290309
In Commercial Distribution

  • 00819824023986 ()
30290309

  • Surgical screwdriver, reusable
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
MET 1 TECHNOLOGIES, LLC
30290308
In Commercial Distribution

  • 00819824023979 ()
30290308

  • Surgical screwdriver, reusable
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
MET 1 TECHNOLOGIES, LLC
30290316
In Commercial Distribution

  • 00819824023894 ()
30290316

  • Orthopaedic inorganic implant inserter/extractor, reusable
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