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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TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 4
Shalby Advanced Technologies, Inc.
3260-1-0004
In Commercial Distribution

  • 00840286848183 ()

  • TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 4
3260-1-0004

  • Knee femur prosthesis trial, reusable
TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 3
Shalby Advanced Technologies, Inc.
3260-1-0003
In Commercial Distribution

  • 00840286848176 ()

  • TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 3
3260-1-0003

  • Knee femur prosthesis trial, reusable
TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 2
Shalby Advanced Technologies, Inc.
3260-1-0002
In Commercial Distribution

  • 00840286848169 ()

  • TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 2
3260-1-0002

  • Knee femur prosthesis trial, reusable
TUKS, TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 1
Shalby Advanced Technologies, Inc.
3260-1-0001
In Commercial Distribution

  • 00840286848152 ()

  • TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 1
3260-1-0001

  • Knee femur prosthesis trial, reusable
TUKS, Tibial Insert/Femoral Impactor, All Plastic
Shalby Advanced Technologies, Inc.
3000-0-0061
In Commercial Distribution

  • 00840286847728 ()

  • Tibial Insert/Femoral Impactor, All Plastic
3000-0-0061

  • Orthopaedic implant impactor, reusable
TUKS, Femoral Stop Drill, Posterior, Long, 5.2mm
Shalby Advanced Technologies, Inc.
3000-1-0052
In Commercial Distribution

  • 00840286847568 ()

  • Femoral Stop Drill, Posterior, Long, 5.2mm
3000-1-0052

  • Fluted surgical drill bit, reusable
TUKS, Femoral Stop Drill, Anterior, Long, 3.7mm
Shalby Advanced Technologies, Inc.
3000-1-0037
In Commercial Distribution

  • 00840286847544 ()

  • Femoral Stop Drill, Anterior, Long, 3.7mm
3000-1-0037

  • Fluted surgical drill bit, reusable
TUKS, Femoral Spherical Reamer, Long, Size 8
Shalby Advanced Technologies, Inc.
3000-1-0108
In Commercial Distribution

  • 00840286847445 ()

  • Femoral Spherical Reamer, Long, Size 8
3000-1-0108

  • Medullary canal orthopaedic reamer, rigid
TUKS, Femoral Spherical Reamer, Long, Size 7
Shalby Advanced Technologies, Inc.
3000-1-0107
In Commercial Distribution

  • 00840286847438 ()

  • Femoral Spherical Reamer, Long, Size 7
3000-1-0107

  • Medullary canal orthopaedic reamer, rigid
TUKS, Femoral Spherical Reamer, Long, Size 6
Shalby Advanced Technologies, Inc.
3000-1-0106
In Commercial Distribution

  • 00840286847421 ()

  • Femoral Spherical Reamer, Long, Size 6
3000-1-0106

  • Medullary canal orthopaedic reamer, rigid
TUKS, Femoral Spherical Reamer, Long, Size 5
Shalby Advanced Technologies, Inc.
3000-1-0105
In Commercial Distribution

  • 00840286847414 ()

  • Femoral Spherical Reamer, Long, Size 5
3000-1-0105

  • Medullary canal orthopaedic reamer, rigid
TUKS, Femoral Spherical Reamer, Long, Size 4
Shalby Advanced Technologies, Inc.
3000-1-0104
In Commercial Distribution

  • 00840286847407 ()

  • Femoral Spherical Reamer, Long, Size 4
3000-1-0104

  • Medullary canal orthopaedic reamer, rigid
TUKS, Femoral Spherical Reamer, Long, Size 3
Shalby Advanced Technologies, Inc.
3000-1-0103
In Commercial Distribution

  • 00840286847391 ()

  • Femoral Spherical Reamer, Long, Size 3
3000-1-0103

  • Medullary canal orthopaedic reamer, rigid
TUKS, Femoral Spherical Reamer, Long, Size 1
Shalby Advanced Technologies, Inc.
3000-1-0101
In Commercial Distribution

  • 00840286847377 ()

  • Femoral Spherical Reamer, Long, Size 1
3000-1-0101

  • Medullary canal orthopaedic reamer, rigid
TUKS, FEMORAL SIZER, CTR HANDLE, SIZE 8
Shalby Advanced Technologies, Inc.
3000-1-1608
In Commercial Distribution

  • 00840286847285 ()

  • FEMORAL SIZER, CTR HANDLE, SIZE 8
3000-1-1608

  • Surgical implant template, reusable
TUKS, FEMORAL SIZER, CTR HANDLE, SIZE 7
Shalby Advanced Technologies, Inc.
3000-1-1607
In Commercial Distribution

  • 00840286847278 ()

  • FEMORAL SIZER, CTR HANDLE, SIZE 7
3000-1-1607

  • Surgical implant template, reusable
TUKS, FEMORAL SIZER, CTR HANDLE, SIZE 6
Shalby Advanced Technologies, Inc.
3000-1-1606
In Commercial Distribution

  • 00840286847261 ()

  • FEMORAL SIZER, CTR HANDLE, SIZE 6
3000-1-1606

  • Surgical implant template, reusable
TUKS, FEMORAL SIZER, CTR HANDLE, SIZE 5
Shalby Advanced Technologies, Inc.
3000-1-1605
In Commercial Distribution

  • 00840286847254 ()

  • FEMORAL SIZER, CTR HANDLE, SIZE 5
3000-1-1605

  • Surgical implant template, reusable
TUKS, FEMORAL SIZER, CTR HANDLE, SIZE 4
Shalby Advanced Technologies, Inc.
3000-1-1604
In Commercial Distribution

  • 00840286847247 ()

  • FEMORAL SIZER, CTR HANDLE, SIZE 4
3000-1-1604

  • Surgical implant template, reusable
TUKS, FEMORAL SIZER, CTR HANDLE, SIZE 3
Shalby Advanced Technologies, Inc.
3000-1-1603
In Commercial Distribution

  • 00840286847230 ()

  • FEMORAL SIZER, CTR HANDLE, SIZE 3
3000-1-1603

  • Surgical implant template, reusable
TUKS, FEMORAL SIZER, CTR HANDLE, SIZE 2
Shalby Advanced Technologies, Inc.
3000-1-1602
In Commercial Distribution

  • 00840286847223 ()

  • FEMORAL SIZER, CTR HANDLE, SIZE 2
3000-1-1602

  • Surgical implant template, reusable
TUKS, FEMORAL SIZER, CTR HANDLE, SIZE 1
Shalby Advanced Technologies, Inc.
3000-1-1601
In Commercial Distribution

  • 00840286847216 ()

  • FEMORAL SIZER, CTR HANDLE, SIZE 1
3000-1-1601

  • Surgical implant template, reusable
TUKS, Femoral IM Rod, Impactor Cap, 4mm
Shalby Advanced Technologies, Inc.
3000-0-0079
In Commercial Distribution

  • 00840286847162 ()

  • Femoral IM Rod, Impactor Cap, 4mm
3000-0-0079

  • Orthopaedic implant impactor, reusable
TUKS, Femoral IM Rod, 4mm x 350mm
Shalby Advanced Technologies, Inc.
3000-0-4350
In Commercial Distribution

  • 00840286847155 ()

  • Femoral IM Rod, 4mm x 350mm
3000-0-4350

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Femoral Resection Indicator, Two Side,1mm
Shalby Advanced Technologies, Inc.
2800-0-0350
In Commercial Distribution

  • 00840286860055 ()

  • Femoral Resection Indicator, Two Side,1mm
2800-0-0350

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Femoral/Tibial Impactor Head Small/Large
Shalby Advanced Technologies, Inc.
2800-0-0701
In Commercial Distribution

  • 00840286855082 ()

  • Femoral/Tibial Impactor Head Small/Large
2800-0-0701

  • Orthopaedic implant impactor, reusable
Femoral Neck Osteotomy Guide, Sz 28mm
Shalby Advanced Technologies, Inc.
1800-1-0000
In Commercial Distribution

  • 00840286841696 ()

  • Femoral Neck Osteotomy Guide, Sz 28mm
1800-1-0000

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Temporary hip spacer with gentamicin. Interspace Tapered Wedge Stem is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device has a rectangular profile stem. Interspace Tapered Wedge Stem is sterile and single-use. InterSpace Tapered Wedge Stem is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Tapered Wedge Stem is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).
TECRES SPA
SPC0523
In Commercial Distribution

  • 08031497001630 ()

  • Length: 211 Millimeter
  • diameter of femoral head: 60 mm


  • Orthopaedic cement spacer
Temporary hip spacer with gentamicin. Interspace Tapered Wedge Stem is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device has a rectangular profile stem. Interspace Tapered Wedge Stem is sterile and single-use. InterSpace Tapered Wedge Stem is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Tapered Wedge Stem is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).
TECRES SPA
SPC0423
In Commercial Distribution

  • 08031497001623 ()

  • Length: 209.2 Millimeter
  • diameter of femoral head: 54 mm


  • Orthopaedic cement spacer
PTCA Drape with Right Transparent Window (Sontara® Material) 77" x 120"
ARGON MEDICAL DEVICES, INC.
396453
In Commercial Distribution

  • 20886333212730 ()
  • 00886333212736 ()

  • 77" x 120" Femoral Angiography Drape
396453

  • Angiographic drape
FEMORAL LUG DRILL
Smith & Nephew, Inc.
E0014993-12
Not in Commercial Distribution

  • 00885556659540 ()
E0014993-12

  • Orthopaedic prosthesis implantation positioning instrument, reusable
FEMORAL HEAD GRASPER
Smith & Nephew, Inc.
E0015117-1
In Commercial Distribution

  • 00885556659137 ()
E0015117-1

  • Bone approximation clamp
FEMORAL INSTRUMENT TRAY
Smith & Nephew, Inc.
71432921
In Commercial Distribution

  • 00885556658192 ()
71432921

  • Instrument tray, reusable
RIGHT FEMORAL ELEVATOR
Smith & Nephew, Inc.
E0014829-2
Not in Commercial Distribution

  • 00885556654477 ()
E0014829-2

  • Bone lever/elevator, reusable
LEFT FEMORAL ELEVATOR
Smith & Nephew, Inc.
E0014829-1
Not in Commercial Distribution

  • 00885556654460 ()
E0014829-1

  • Bone lever/elevator, reusable
FEMORAL LUG DRILL
Smith & Nephew, Inc.
E0015011-1
Not in Commercial Distribution

  • 00885556646717 ()
E0015011-1

  • Surgical drill guide, reusable
FEMORAL LUG DRILL
Smith & Nephew, Inc.
E0015015-1
Not in Commercial Distribution

  • 00885556644492 ()
E0015015-1

  • Surgical drill guide, reusable
LEGION FEMORAL RULER
Smith & Nephew, Inc.
E0015316-1
In Commercial Distribution

  • 00885556672365 ()
E0015316-1

  • General internal orthopaedic fixation system implantation kit
ANTERIOR FEMORAL STYLUS
Smith & Nephew, Inc.
E0015144-4
In Commercial Distribution

  • 00885556667996 ()
E0015144-4

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DISTAL FEMORAL STYLUS
Smith & Nephew, Inc.
E0015144-3
In Commercial Distribution

  • 00885556667989 ()
E0015144-3

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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