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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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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

NanoPhix Instrument Kit - B487EXINN9115000

NanoPhix sterile instrument kit. The kit contains 1 depth gauge, 2 guide wires, 1 driver.
Exsomed Corporation
EXINN911500
Not in Commercial Distribution

  • B487EXINN9115000 ()
EXINN911500

  • Surgical depth gauge, single-use
  • Orthopaedic guidewire, single-use
  • Orthopaedic implant driver

InFrame Instrument Kit - B487EXINF9120000

InFrame sterile instrument kit. The kit contains two step guide wires, one cannulated drill, one depth gauge
Exsomed Corporation
EXINF912000
Not in Commercial Distribution

  • B487EXINF9120000 ()
EXINF912000

  • Surgical depth gauge, single-use
  • Orthopaedic guidewire, single-use
  • Orthopaedic implant driver

SLX Insertion Tool - 00811954012656

No Description
INTERVENTIONAL SPINE, INC
6004
In Commercial Distribution

  • 00811954012656 ()
6004

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

Insertion Tool - 81195401040924

No Description
INTERVENTIONAL SPINE, INC
6095
In Commercial Distribution

  • 81195401040924 ()
6095

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

ArrowPhix System - B487EXARR9025260

ArrowPhix Compression Screw System The System includes the implant, two guide wires, and one driver.
Exsomed Corporation
EXARR902526
Not in Commercial Distribution

  • B487EXARR9025260 ()

  • Length: 26 Millimeter
  • Outer Diameter: 2.5 Millimeter
EXARR902526

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Orthopaedic bone screw, non-bioabsorbable, sterile

INnate Instrument Kit - B487EXINN9145000

INnate Sterile Instrument Kit The kit contains two guide wires, one cannulated drill, and one cannulated driver.
Exsomed Corporation
EXINN914500
Not in Commercial Distribution

  • B487EXINN9145000 ()
EXINN914500

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Surgical depth gauge, single-use

INnate Instrument Kit - B487EXINN9136000

INnate Sterile Instrument Kit The kit contains two guide wires, one cannulated drill, and one cannulated driver.
Exsomed Corporation
EXINN913600
Not in Commercial Distribution

  • B487EXINN9136000 ()
EXINN913600

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Surgical depth gauge, single-use

ArcPhix System - B487EXARC9030280

ArcPhix Compression Screw System The system includes the implant, two guide wires, one cannulated drill, and a driver.
Exsomed Corporation
EXARC903028
Not in Commercial Distribution

  • B487EXARC9030280 ()

  • Length: 28 Millimeter
  • Outer Diameter: 3.0 Millimeter
EXARC903028

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Orthopaedic bone screw (non-sliding)
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