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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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NIDO Pedicle Screw System - B07315K0100600

Caddie, Modular Bone Screws
Kalitec Direct LLC
15-K01-0060
In Commercial Distribution

  • B07315K0100600 ()
15-K01-0060

  • Surgical instrument/implant rack

NIDO Pedicle Screw System - B07315K0100440

Caddie, Locking Caps
Kalitec Direct LLC
15-K01-0044
In Commercial Distribution

  • B07315K0100440 ()
15-K01-0044

  • Surgical instrument/implant rack

Inseption - B07314KJ0100300

Caddie Lid, ISP Implants, Hinged
Kalitec Direct LLC
14-K01-0030
In Commercial Distribution

  • B07314KJ0100300 ()
14-K01-0030

  • Surgical instrument/implant rack

InSePtion MIS Fixation System - B07314K0600110

Tray Insert, ISP, Implant
Kalitec Direct LLC
14-K06-0011
In Commercial Distribution

  • B07314K0600110 ()


  • Surgical instrument/implant rack

Inseption - B07314K0100310

Assembly, Caddie, ISP Implants, Hinged
Kalitec Direct LLC
14-K01-0031
In Commercial Distribution

  • B07314K0100310 ()
14-K01-0031

  • Surgical instrument/implant rack

InSePtion MIS Fixation System - B07314K0100210

Caddie Lid, Implant
Kalitec Direct LLC
14-K01-0021
In Commercial Distribution

  • B07314K0100210 ()


  • Surgical instrument/implant rack

InSePtion MIS Fixation System - B07314K0100200

Caddie, Implant
Kalitec Direct LLC
14-K01-0020
In Commercial Distribution

  • B07314K0100200 ()


  • Surgical instrument/implant rack

ANCHORAGE - 07613327171297

Screw Rack CP
Stryker GmbH
940469
In Commercial Distribution

  • 07613327171297 ()
940469

  • Surgical instrument/implant rack

VARIAX - 07613327126211

Screw Rack Lid
Stryker GmbH
940176
In Commercial Distribution

  • 07613327126211 ()
940176

  • Surgical instrument/implant rack

VARIAX - 07613327126167

Screw Rack
Stryker GmbH
940163
In Commercial Distribution

  • 07613327126167 ()
940163

  • Surgical instrument/implant rack
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