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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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OrthoMedFlex - M7161111814010

Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1401
In Commercial Distribution

  • M7161111814010 ()
111-18-1401

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111813010

Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1301
In Commercial Distribution

  • M7161111813010 ()
111-18-1301

  • Press-fit femoral stem prosthesis

Origin 125° Short Neck Hip Stem - 09348215083557

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0825
In Commercial Distribution

  • 09348215083557 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215083540

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0806
In Commercial Distribution

  • 09348215083540 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024093

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1625
In Commercial Distribution

  • 09348215024093 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024079

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1425
In Commercial Distribution

  • 09348215024079 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024062

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1325
In Commercial Distribution

  • 09348215024062 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024055

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1225
In Commercial Distribution

  • 09348215024055 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024031

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1025
In Commercial Distribution

  • 09348215024031 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215024017

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1806
In Commercial Distribution

  • 09348215024017 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023997

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1506
In Commercial Distribution

  • 09348215023997 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023980

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1406
In Commercial Distribution

  • 09348215023980 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023966

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1206
In Commercial Distribution

  • 09348215023966 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023942

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1006
In Commercial Distribution

  • 09348215023942 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215023836

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0803
In Commercial Distribution

  • 09348215023836 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024109

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1825
In Commercial Distribution

  • 09348215024109 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024086

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1525
In Commercial Distribution

  • 09348215024086 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024048

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1125
In Commercial Distribution

  • 09348215024048 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024024

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0925
In Commercial Distribution

  • 09348215024024 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215024000

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1606
In Commercial Distribution

  • 09348215024000 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023973

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1306
In Commercial Distribution

  • 09348215023973 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023959

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1106
In Commercial Distribution

  • 09348215023959 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023935

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0906
In Commercial Distribution

  • 09348215023935 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017835

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1803
In Commercial Distribution

  • 09348215017835 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017828

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1603
In Commercial Distribution

  • 09348215017828 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017811

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1503
In Commercial Distribution

  • 09348215017811 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017804

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1403
In Commercial Distribution

  • 09348215017804 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017798

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1303
In Commercial Distribution

  • 09348215017798 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017781

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1203
In Commercial Distribution

  • 09348215017781 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017774

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1103
In Commercial Distribution

  • 09348215017774 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017767

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1003
In Commercial Distribution

  • 09348215017767 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017750

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0903
In Commercial Distribution

  • 09348215017750 ()


  • Coated femoral stem prosthesis, modular

microTargeting™ Electrode and Insertion Tube Kit - 10873263001346

microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame and STar Drive. Contains: IT(AR16): Insertion Tube. IT(AR17): Insertion Tube w/ Stylet. MTDWLN(AR)(AR2): microTargeting Electrode. 66-CN-ET: Insertion Tube Extractor. Individual Specifications: IT(AR16) - 135mm tube length, 1.981mm OD, 0.96mm ID. IT(AR17) - 243.5mm tube length, 0.902mm OD, 0.597mm ID, 264mm stylet length (includes collar). MTDWLN(AR)(AR2) - 276.5mm electrode length, 10mm differential, 261.5mm protective tube length, 0.55mm OD. DZAP(L) 1 Meg
FHC, INC.
KTF1002-00134
Not in Commercial Distribution

  • 10873263001346 ()
  • 00873263001349 ()
KTF1002

  • Intracerebral cannula, implantable
  • Depth electrode

microTargeting™ Electrode and Insertion Tube Kit - 10873263001322

Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTargeting Drive. Contains: IT(AR8): Insertion Tube w/ Stylet. MTDPBN(PA)(DB2): microTargeting Electrode. Individual Specifications: IT(AR8) - 217mm tube length, 0.89mm OD, 0.58mm ID MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm differential length, 234.2mm protective tube length. 1 Meg RZAP, 0.56mm od
FHC, INC.
FC7100-00132
Not in Commercial Distribution

  • 10873263001322 ()
  • 00873263001325 ()
FC7100

  • Intracerebral cannula, implantable
  • Depth electrode

microTargeting™ Electrode and Insertion Tube Kit - 10873263001162

microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDrive or mT Drive. Each box contains: 2x MTDPLN(PA)(DB2) D.ZAP Differential Electrode. 1x IT(DB3) Insertion tube with Stylet. 1x PT(DB5) Protective Tube. Individual Specifications: MTDPLN(PA)(DB2) - 249.2mm electrode length, 10mm tip exposure, 234.2mm protective tube length, .56mm od, 1.0 meg DZAP(L) IT(DB3) - 194mm length, 1.8mm od, 1.6mm id, PT(DB5) - 194mm length, 1.47mm od, 0.99mm id
FHC, INC.
FC4001-00116
Not in Commercial Distribution

  • 10873263001162 ()
  • 00873263001165 ()
FC4001

  • Depth electrode
  • Intracerebral cannula, implantable

microTargeting™ Electrode and Insertion Tube - 10873263001155

microTargeting single electrode insertion tubes and electrodes kit, 5x, Sterile for use with NexFrame and NexDrive or mT Drive. Each Box Contains: 2x MTDPBN(PA)(DB2) Electrode. 1x IT(DB3) Insertion Tube with Stylet. 1x PT(DB5) Spacer Tube. Individual Specifications: MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm tip expsure, 234.3mm protective tube length, 0.56mm od, 1.0 meg. RZAP IT(DB3) - 194mm length, 1.8mm od, 1.6mm id. PT(DB5) - 194mm length, 1.47mm od, 0.99mm id.
FHC, INC.
FC4000-00115
Not in Commercial Distribution

  • 10873263001155 ()
  • 00873263001158 ()
FC4000

  • Depth electrode
  • Intracerebral cannula, implantable

Origin 125° Short Neck Collared Hip Stem - 09348215083564

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0826
In Commercial Distribution

  • 09348215083564 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024192

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1826
In Commercial Distribution

  • 09348215024192 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024178

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1526
In Commercial Distribution

  • 09348215024178 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024161

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1426
In Commercial Distribution

  • 09348215024161 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024147

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1226
In Commercial Distribution

  • 09348215024147 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024130

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1126
In Commercial Distribution

  • 09348215024130 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024116

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0926
In Commercial Distribution

  • 09348215024116 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024185

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1626
In Commercial Distribution

  • 09348215024185 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024154

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1326
In Commercial Distribution

  • 09348215024154 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024123

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1026
In Commercial Distribution

  • 09348215024123 ()


  • Coated femoral stem prosthesis, modular

microTargeting™ Electrode and Insertion Tube Kit - 00873263005088

microTargeting Frame Kit D.ZAP/Lead Insertion, 1x, Sterile, for use with mT Drive or STar Drive. Contains: 34685L: Single D.ZAP Electrode. 66-DA-SD: Drape Sleeve. 66-EL-LP: Patient Lead for LP+. 66-IT-05P: Single Insertion Tube Set.
FHC, INC.
KT-FPK-S20-00508
In Commercial Distribution

  • 00873263005088 ()
KT-FPK-S20

  • Depth electrode
  • Neurological stereotactic surgery system
  • Intracerebral cannula, implantable

microTargeting™ Procedure Kit - 00873263003664

microTargeting Platform Procedure Consumables Kit, 1x, sterile, for use with mT or STar Drive, mT Platform and Guideline 4000 LP+. Contains: 44975L: D.ZAP Tungsten Differential Electrode - - 220.72mm electrode length, 10mm differential, 205.72mm protective tube length, DZAP(L) 1Meg, 0.55mm od. 66-DA-SD: Sterile Drape Sleeve for motor 66-EL-LP: Patient Lead for Guideline 4000 LP+ 66-IT-03P: Sterile Single Insertion Tube Set - IT(MP1) - 184.1mm tube length, 1.83mm od, 1.6mm id with Stylet PT(MP1) - Diameter reduction tube 0.58mm id
FHC, INC.
KT-PPK-S-00366
In Commercial Distribution

  • 00873263003664 ()
KT-PPK-S

  • Depth electrode
  • Patient surgical drape, single-use
  • Intracerebral cannula, implantable

microTargeting™ Single Procedure Kit - 00873263001332

microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tube. 2x MTDWLN(BP)(BP7): microTargeting Electrode. PT(BP2): Protective Tube. Sterile Drape Sleeve for microTargeting motor FC1020 Electrode Lead Individual Specifications: IT(BP2) - 183mm tube length, 1.829mm OD, 1.6mm ID, 184mm stylet (not including collar). MTDWLN(BP)(BP7) - 271.4mm electrode length, 10mm differential, 256.4mm protective tube length, 0.77mm OD. 1Meg DZAP(L) PT(PB2) - 181mm tube length, 1.47mm OD, 0.99mm ID OD: 0.77mm
FHC, INC.
KTF1001-00133
Not in Commercial Distribution

  • 00873263001332 ()
KTF1001

  • Patient surgical drape, single-use
  • Intracerebral cannula, implantable
  • Depth electrode

Asfora Bullet Cage® System - M364119902FD80

16mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD8
In Commercial Distribution

  • 1199028 ()
  • M364119902FD80 ()

  • Outer Diameter: 16 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
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