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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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FacetLINK MI - 00817329024507

Trocar Stylet
LINKSPINE, INC.
80-2510
In Commercial Distribution

  • 00817329024507 ()
80-2510

  • Trans-facet-screw internal spinal fixation system, non-sterile

FacetLINK MI - 00817329024491

Dilator Handle
LINKSPINE, INC.
80-2505
In Commercial Distribution

  • 00817329024491 ()
80-2505

  • Trans-facet-screw internal spinal fixation system, non-sterile

FacetLINK MI - 00817329024484

Dilator 3
LINKSPINE, INC.
80-2503
In Commercial Distribution

  • 00817329024484 ()
80-2503

  • Trans-facet-screw internal spinal fixation system, non-sterile

FacetLINK MI - 00817329024477

Dilator 2
LINKSPINE, INC.
80-2502
In Commercial Distribution

  • 00817329024477 ()
80-2502

  • Trans-facet-screw internal spinal fixation system, non-sterile

FacetLINK MI - 00817329024460

Dilator 1
LINKSPINE, INC.
80-2501
In Commercial Distribution

  • 00817329024460 ()
80-2501

  • Trans-facet-screw internal spinal fixation system, non-sterile

ZAVATION - 00842166192263

Non-Cannulated Facet Drill
Zavation LLC
290-2015
In Commercial Distribution

  • 00842166192263 ()


  • Trans-facet-screw internal spinal fixation system, non-sterile

ProAdjuster Kidz - 00860011416494

Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobilization of musculoskeletal joints that provides impulsive single and multiple thrusts over manually selectable force settings.
Neuromechanical Innovations, L.L.C.
ProAdjuster Kidz
Not in Commercial Distribution

  • 00860011416494 ()


  • Joint/spinal manipulator, electronic

Prosoft SRT - 00860011416487

Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobilization of musculoskeletal tissues that provides impulsive single and multiple thrusts over three selectable force settings.
Neuromechanical Innovations, L.L.C.
Prosoft SRT
In Commercial Distribution

  • 00860011416487 ()


  • Joint/spinal manipulator, electronic

ProAdjuster SRT - 00860011416470

Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobilization of musculoskeletal joints that provides impulsive single and multiple thrusts over three selectable force settings.
Neuromechanical Innovations, L.L.C.
ProAdjuster SRT
In Commercial Distribution

  • 00860011416470 ()


  • Joint/spinal manipulator, electronic

Prosports 360 - 00860011416463

Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobilization of musculoskeletal joints that provides impulsive single and multiple thrusts over three selectable force settings.
Neuromechanical Innovations, L.L.C.
Prosports 360
In Commercial Distribution

  • 00860011416463 ()


  • Joint/spinal manipulator, electronic
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