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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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Reduction Locking Polyaxial Driver
PRECISION SPINE, INC.
39-SP-0740
In Commercial Distribution

  • 00840019935890 ()
39-SP-0740

  • Orthopaedic surgical procedure kit, non-medicated, 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
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
30290332
In Commercial Distribution

  • 00819824023832 ()
30290332

  • 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
300290347
In Commercial Distribution

  • 00819824023788 ()
30290347

  • 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
30290348
In Commercial Distribution

  • 00819824023757 ()
30290348

  • Orthopaedic inorganic implant inserter/extractor, 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
30290310
In Commercial Distribution

  • 00819824023627 ()
30290310

  • Surgical screwdriver, reusable
Driver, T15 NSR, 200mm, AO Quick Connect
GLOBUS MEDICAL, INC.
6187.3815
In Commercial Distribution

  • 00889095716634 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Driver, T15 SR, 170mm, AO Quick Connect
GLOBUS MEDICAL, INC.
6187.3715
In Commercial Distribution

  • 00889095716610 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
8mm Self Retaining Driver Shaft
GLOBUS MEDICAL, INC.
6183.1102
In Commercial Distribution

  • 00889095711745 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Retention Bolt Driver
GLOBUS MEDICAL, INC.
6176.0027
In Commercial Distribution

  • 00889095711318 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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