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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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primaLOK FF - 00813210021969

primaLOK FF 30mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1130-00
In Commercial Distribution

  • 00813210021969 ()

  • Length: 30 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile

microTargeting™ Electrodes - 10873263007553

microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00755
In Commercial Distribution

  • 10873263007553 ()
  • 00873263007556 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Length: 249.2 Millimeter
FC5000

  • Depth electrode

microTargeting™ Electrodes - 10873263007522

microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00752
In Commercial Distribution

  • 10873263007522 ()
  • 00873263007525 ()

  • Length: 227.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
FC2004

  • Depth electrode

microTargeting™ Electrodes - 10873263001292

microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00129
Not in Commercial Distribution

  • 10873263001292 ()
  • 00873263001295 ()

  • Length: 227.2 Millimeter
  • Length: 242.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
FC2004

  • Depth electrode

microTargeting™ Electrodes - 10873263001179

microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00117
Not in Commercial Distribution

  • 10873263001179 ()
  • 00873263001172 ()

  • Length: 249.2 Millimeter
  • Length: 10 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
FC5000

  • Depth electrode

microTargeting™ Electrode - 00873263006726

microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation, Presterile
FHC, INC.
MTBPBP(DT1)-00672
In Commercial Distribution

  • 10873263006723 ()
  • 00873263006726 ()

  • Length: 300 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.63 Millimeter
  • Impedance: Megaohms
MTBPBP(DT1)

  • Depth electrode

microTargeting™ Electrode - 00873263006429

microTargeting(TM) Electrode, sterile, D.ZAP(Z), for use with Platform
FHC, INC.
MTDPZP(PA)(MP1)-00642
In Commercial Distribution

  • 10873263006426 ()
  • 00873263006429 ()

  • Length: 215.72 Millimeter
  • Outer Diameter: 0.5 Millimeter
  • Length: 10 Millimeter
  • Length: 220.72 Millimeter
  • Impedance: Megaohms
MTDPZP(PA)(MP1)

  • Depth electrode

microTargeting™ Electrode - 00873263006405

microTargeting(TM) Electrode, sterile, 5x, D.ZAP(L), for use with Platform
FHC, INC.
MTDPLP(PA)(MP1)-00640
In Commercial Distribution

  • 10873263006402 ()
  • 00873263006405 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.5 Millimeter
  • Length: 220.72 Millimeter
  • Length: 215.72 Millimeter
  • Length: 10 Millimeter
MTDPLP(PA)(MP1)

  • Depth electrode

microTargeting™ Electrode - 00873263005781

microTargeting(TM) Electrode, sterile, for use with Nexframe(R) and STar Drive
FHC, INC.
5700R-00578
In Commercial Distribution

  • 10873263005788 ()
  • 00873263005781 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 242.2 Millimeter
  • Length: 227.2 Millimeter
5700R

  • Depth electrode

microTargeting™ Electrode - 00873263005743

microTargeting(TM) Electrode, sterile, for use with Nexframe(R)
FHC, INC.
5000R-00574
In Commercial Distribution

  • 10873263005740 ()
  • 00873263005743 ()

  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
5000R

  • Depth electrode

microTargeting™ Electrode - 00873263005040

microTargeting(TM) Electrode, array, differential, 1 Meg, sterile, for Nexframe
FHC, INC.
MER-5000T-00504
In Commercial Distribution

  • 10873263005047 ()
  • 00873263005040 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 244.22 Millimeter
  • Length: 234.22 Millimeter
MER-5000T

  • Depth electrode

microTargeting™ Electrode - 00873263004647

microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(NS)(SL2)-00464
In Commercial Distribution

  • 10873263004644 ()
  • 00873263004647 ()

  • Length: 10 Millimeter
  • Length: 274.65 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 258 Millimeter
MTDWZP(NS)(SL2)

  • Depth electrode

microTargeting™ Electrode - 00873263004623

microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(NS)(SK2)-00462
In Commercial Distribution

  • 10873263004620 ()
  • 00873263004623 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 243.65 Millimeter
  • Length: 227 Millimeter
MTDWZP(NS)(SK2)

  • Depth electrode

microTargeting™ Electrode - 00873263004548

microTargeting Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(BP)(BP5)-00454
In Commercial Distribution

  • 10873263004545 ()
  • 00873263004548 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 265 Millimeter
  • Length: 215 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTDWZP(BP)(BP5)

  • Depth electrode

microTargeting™ Electrode - 00873263004500

microTargeting(TM) Electrode, 5x, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(AR)(DB1)-00450
In Commercial Distribution

  • 10873263004507 ()
  • 00873263004500 ()

  • Length: 234.22 Millimeter
  • Length: 10 Millimeter
  • Length: 249.22 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
MTDWZP(AR)(DB1)

  • Depth electrode

microTargeting™ Electrode - 00873263003985

microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), sterile
FHC, INC.
MTDWLP(BP)(BP6)-00398
In Commercial Distribution

  • 10873263003982 ()
  • 00873263003985 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 277 Millimeter
  • Length: 227 Millimeter
MTDWLP(BP)(BP6)

  • Depth electrode

microTargeting™ Electrode - 00873263003909

microTargeting(TM) Electrode, differential, tungsten, sterile
FHC, INC.
MTDWBP(SB)(SB2)-00390
In Commercial Distribution

  • 10873263003906 ()
  • 00873263003909 ()

  • Length: 260 Millimeter
  • Impedance: Megaohms
  • Length: 6 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 272.65 Millimeter
MTDWBP(SB)(SB2)

  • Depth electrode

microTargeting™ Electrode - 00873263003886

microTargeting(TM) Electrode, differential, tungsten, sterile
FHC, INC.
MTDWBP(LS)(LS3)-00388
In Commercial Distribution

  • 10873263003883 ()
  • 00873263003886 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 291.5 Millimeter
  • Length: 273.5 Millimeter
MTDWBP(LS)(LS3)

  • Depth electrode

microTargeting™ Electrode - 00873263003589

microTargeting(TM) Electrode, differential, platinum/iridium, epoxylite insulated, sterile, D.ZAP(Z)
FHC, INC.
MTDPZP(NS)(SL2)-00358
In Commercial Distribution

  • 10873263003586 ()
  • 00873263003589 ()

  • Impedance: Megaohms
  • Length: 258 Millimeter
  • Length: 274.65 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
MTDPZP(NS)(SL2)

  • Depth electrode

microTargeting™ Electrode - 00873263003459

microTargeting(TM) Electrode, differential, platinum/iridium, epoxy insulated, sterile, D.ZAP(Z)
FHC, INC.
MTDPZP(EP)(BP7)-00345
In Commercial Distribution

  • 10873263003456 ()
  • 00873263003459 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.86 Millimeter
  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
MTDPZP(EP)(BP7)

  • Depth electrode

microTargeting™ Electrode - 00873263003411

microTargeting Electrode, differential, platinum/iridium, glass insulated, specify Z, sterile
FHC, INC.
MTDPXP(BP)(BP7)-00341
In Commercial Distribution

  • 10873263003418 ()
  • 00873263003411 ()

  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Outer Diameter: 0.86 Millimeter
MTDPXP(BP)(BP7)

  • Depth electrode

microTargeting™ Electrode - 00873263003268

microTargeting(TM) Electrode, differential, sterile, platinum/iridium, glass insulated
FHC, INC.
MTDPBP(LS)(LS3)-00326
In Commercial Distribution

  • 10873263003265 ()
  • 00873263003268 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 291.5 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Length: 273.5 Millimeter
MTDPBP(LS)(LS3)

  • Depth electrode

microTargeting™ Electrode - 00873263002896

microTargeting(TM) Electrode, sterile, D.ZAP(Z), for Nexframe(R) and STar(R) Drive
FHC, INC.
5705Z-00289
In Commercial Distribution

  • 10873263002893 ()
  • 00873263002896 ()

  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 227.2 Millimeter
  • Length: 242.2 Millimeter
5705Z

  • Depth electrode

microTargeting™ Electrode - 00873263002834

microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Nexframe(R) and STar Drive
FHC, INC.
5705L-00283
In Commercial Distribution

  • 10873263002831 ()
  • 00873263002834 ()

  • Length: 227.2 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Impedance: Megaohms
5705L

  • Depth electrode

microTargeting™ Electrode - 00873263002773

microTargeting(TM) Electrode, sterile, D.ZAP(Z), for use with Nexframe(R)
FHC, INC.
5005Z-00277
In Commercial Distribution

  • 10873263002770 ()
  • 00873263002773 ()

  • Impedance: Megaohms
  • Length: 234.2 Millimeter
  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
5005Z

  • Depth electrode

microTargeting™ Electrode - 00873263002735

microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Nexframe(R)
FHC, INC.
5005L-00273
In Commercial Distribution

  • 10873263002732 ()
  • 00873263002735 ()

  • Length: 249.2 Millimeter
  • Length: 10 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
5005L

  • Depth electrode

microTargeting™ Electrode - 00873263002674

microTargeting(TM) Electrode, sterile, D.Zap(Z), for use with Platform
FHC, INC.
44975Z-00267
In Commercial Distribution

  • 10873263002671 ()
  • 00873263002674 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 205.72 Millimeter
  • Length: 10 Millimeter
  • Length: 220.72 Millimeter
44975Z

  • Depth electrode

microTargeting™ Electrode - 00873263002636

microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Platform
FHC, INC.
44975L-00263
In Commercial Distribution

  • 10873263002633 ()
  • 00873263002636 ()

  • Impedance: Megaohms
  • Length: 220.72 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 205.72 Millimeter
44975L

  • Depth electrode

microTargeting™ Electrode - 00873263002599

microTargeting(TM) Electrode, 1x, sterile, R.ZAP, Platform
FHC, INC.
44970R-00259
In Commercial Distribution

  • 10873263002596 ()
  • 00873263002599 ()

  • Length: 205.72 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 10 Millimeter
44970R

  • Depth electrode

microTargeting™ Electrode - 00873263002544

microTargeting(TM) Electrode, 1x, sterile, single, D.ZAP(Z), T=30 for use with Frame and STar or MT Drive
FHC, INC.
34685Z-00254
In Commercial Distribution

  • 10873263002541 ()
  • 00873263002544 ()

  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
34685Z

  • Depth electrode
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