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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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Ax® - M711LS4480

SST
Innovasis, Inc.
LS-448
In Commercial Distribution

  • M711LS4480 ()


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

Kestrel® - M711LS4360

SST
Innovasis, Inc.
LS-436
In Commercial Distribution

  • M711LS4360 ()
LS-436

  • Orthopaedic implant driver

Kestrel® - M711LS4340

SST, Al, Silicone
Innovasis, Inc.
LS-434
In Commercial Distribution

  • M711LS4340 ()
LS-434

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

Neuro & Craniofacial Fixation System - M711LS4190

Al
Innovasis, Inc.
LS-419
In Commercial Distribution

  • M711LS4190 ()
LS-419

  • Orthopaedic implant driver

Tx™ - M711LS3960

SST, Silicone, PEEK
Innovasis, Inc.
LS-396
In Commercial Distribution

  • M711LS3960 ()


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

Tx™ - M711LS3950

Al, Silicone, SST
Innovasis, Inc.
LS-395
In Commercial Distribution

  • M711LS3950 ()


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

Ax® - M711LS3940

SST
Innovasis, Inc.
LS-394
In Commercial Distribution

  • M711LS3940 ()


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

Ax® - M711LS3880

Al, Silicone, SST
Innovasis, Inc.
LS-388
In Commercial Distribution

  • M711LS3880 ()


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

LxHA™ Angled Lateral - M711LS3870

SST, Silicone, Al
Innovasis, Inc.
LS-387
In Commercial Distribution

  • M711LS3870 ()


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

Ax® - M711LS3560

Al, Silicone, SST
Innovasis, Inc.
LS-356
In Commercial Distribution

  • M711LS3560 ()


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