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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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Three Prong Driver - 00811954012762

No Description
INTERVENTIONAL SPINE, INC
6015
In Commercial Distribution

  • 00811954012762 ()
6015

  • General internal orthopaedic fixation system implantation kit
  • Orthopaedic implant driver

Opteryx® - M711CI0100

Radel, SST
Innovasis, Inc.
CI-010
In Commercial Distribution

  • M711CI0100 ()
CI-010

  • Orthopaedic implant driver
  • Surgical screwdriver, reusable

Ax® - M711LS3090

SST
Innovasis, Inc.
LS-309
In Commercial Distribution

  • M711LS3090 ()


  • Orthopaedic implant driver
  • Surgical screwdriver, reusable

Excella II® - M711LS1600

Al, Silicone, SST
Innovasis, Inc.
LS-160
In Commercial Distribution

  • M711LS1600 ()


  • Orthopaedic implant driver
  • Surgical screwdriver, reusable

3.5/4.5mm Non-Cannulated Driver - 00811954012892

No Description
INTERVENTIONAL SPINE, INC
6029
In Commercial Distribution

  • 00811954012892 ()
6029

  • General internal orthopaedic fixation system implantation kit
  • Orthopaedic implant driver

3.5/4.5mm Cannulated Driver - 00811954012885

No Description
INTERVENTIONAL SPINE, INC
6028
In Commercial Distribution

  • 00811954012885 ()
6028

  • Orthopaedic implant driver
  • General internal orthopaedic fixation system implantation kit

FixxSure® - M711LS4530

SST, Radel
Innovasis, Inc.
LS-453
In Commercial Distribution

  • M711LS4530 ()


  • Orthopaedic implant driver
  • Orthopaedic fixation implant alignment tool

Opteryx® - M711CI1100

SST
Innovasis, Inc.
CI-110
In Commercial Distribution

  • M711CI1100 ()
CI-110

  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver

LxHA™ - M711LS5080

SST, Silicone, Al, Adhesive
Innovasis, Inc.
LS-508
In Commercial Distribution

  • M711LS5080 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Orthopaedic implant driver

Tx™ - M711LS4490

SST
Innovasis, Inc.
LS-449
In Commercial Distribution

  • M711LS4490 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Orthopaedic implant driver
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