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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RKS, Trial, Augment, Distal Femoral, Size 1
Shalby Advanced Technologies, Inc.
2979-0-0001
In Commercial Distribution

  • 00840286842969 ()

  • Trial, Augment, Distal Femoral, Size 1
2979-0-0001

  • Knee femur prosthesis trial, reusable
RKS, Trial, Augment, Distal Femoral, Size 2
Shalby Advanced Technologies, Inc.
2979-0-0002
In Commercial Distribution

  • 00840286842952 ()

  • Trial, Augment, Distal Femoral, Size 2
2979-0-0002

  • Knee femur prosthesis trial, reusable
RKS, Trial, Augment, Posterior Femoral, Size 1
Shalby Advanced Technologies, Inc.
2979-0-1001
In Commercial Distribution

  • 00840286842921 ()

  • Trial, Augment, Posterior Femoral, Size 1
2979-0-1001

  • Knee femur prosthesis trial, reusable
RKS, Trial, Augment, Posterior Femoral, Size 2
Shalby Advanced Technologies, Inc.
2979-0-1002
In Commercial Distribution

  • 00840286842914 ()

  • Trial, Augment, Posterior Femoral, Size 2
2979-0-1002

  • Knee femur prosthesis trial, reusable
RKS, Trial, Augment, Posterior Femoral, Size 3
Shalby Advanced Technologies, Inc.
2979-0-1003
In Commercial Distribution

  • 00840286842907 ()

  • Trial, Augment, Posterior Femoral, Size 3
2979-0-1003

  • Knee femur prosthesis trial, reusable
RKS, Trial, Augment, Posterior Femoral, Size 4
Shalby Advanced Technologies, Inc.
2979-0-1004
In Commercial Distribution

  • 00840286842891 ()

  • Trial, Augment, Posterior Femoral, Size 4
2979-0-1004

  • Knee femur prosthesis trial, reusable
RKS, Trial, Augment, Posterior Femoral, Size 5
Shalby Advanced Technologies, Inc.
2979-0-1005
In Commercial Distribution

  • 00840286842884 ()

  • Trial, Augment, Posterior Femoral, Size 5
2979-0-1005

  • Knee femur prosthesis trial, reusable
RKS, Trial, Augment, Posterior Femoral, Size 6
Shalby Advanced Technologies, Inc.
2979-0-1006
In Commercial Distribution

  • 00840286842877 ()

  • Trial, Augment, Posterior Femoral, Size 6
2979-0-1006

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Right, Size 1
Shalby Advanced Technologies, Inc.
2976-0-0001
In Commercial Distribution

  • 00840286842433 ()

  • Trial, Femoral Component, Right, Size 1
2976-0-0001

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Right, Size 2
Shalby Advanced Technologies, Inc.
2976-0-0002
In Commercial Distribution

  • 00840286842426 ()

  • Trial, Femoral Component, Right, Size 2
2976-0-0002

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Right, Size 3
Shalby Advanced Technologies, Inc.
2976-0-0003
In Commercial Distribution

  • 00840286842419 ()

  • Trial, Femoral Component, Right, Size 3
2976-0-0003

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Right, Size 4
Shalby Advanced Technologies, Inc.
2976-0-0004
In Commercial Distribution

  • 00840286842402 ()

  • Trial, Femoral Component, Right, Size 4
2976-0-0004

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Right, Size 5
Shalby Advanced Technologies, Inc.
2976-0-0005
In Commercial Distribution

  • 00840286842396 ()

  • Trial, Femoral Component, Right, Size 5
2976-0-0005

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Right, Size 6
Shalby Advanced Technologies, Inc.
2976-0-0006
In Commercial Distribution

  • 00840286842389 ()

  • Trial, Femoral Component, Right, Size 6
2976-0-0006

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Left, Size 1
Shalby Advanced Technologies, Inc.
2975-0-0001
In Commercial Distribution

  • 00840286842303 ()

  • Trial, Femoral Component, Left, Size 1
2975-0-0001

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Left, Size 2
Shalby Advanced Technologies, Inc.
2975-0-0002
In Commercial Distribution

  • 00840286842297 ()

  • Trial, Femoral Component, Left, Size 2
2975-0-0002

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Left, Size 3
Shalby Advanced Technologies, Inc.
2975-0-0003
In Commercial Distribution

  • 00840286842280 ()

  • Trial, Femoral Component, Left, Size 3
2975-0-0003

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Left, Size 4
Shalby Advanced Technologies, Inc.
2975-0-0004
In Commercial Distribution

  • 00840286842273 ()

  • Trial, Femoral Component, Left, Size 4
2975-0-0004

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Left, Size 5
Shalby Advanced Technologies, Inc.
2975-0-0005
In Commercial Distribution

  • 00840286842266 ()

  • Trial, Femoral Component, Left, Size 5
2975-0-0005

  • Knee femur prosthesis trial, reusable
RKS, Trial, Femoral Component, Left, Size 6
Shalby Advanced Technologies, Inc.
2975-0-0006
In Commercial Distribution

  • 00840286842259 ()

  • Trial, Femoral Component, Left, Size 6
2975-0-0006

  • Knee femur prosthesis trial, reusable
Femoral Resection Indicator, Two Sided, 1.27mm
Shalby Advanced Technologies, Inc.
2810-0-0350
In Commercial Distribution

  • 00840286842099 ()

  • Femoral Resection Indicator, Two Sided, 1.27mm
2810-0-0350

  • Orthopaedic prosthesis implantation positioning instrument, 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
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
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
No Description
Zimmer, Inc.
6216-01-112
In Commercial Distribution

  • 00889024252912 ()

  • Femoral Speed Block .040, Size 5
6216-01-112

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
6216-01-111
In Commercial Distribution

  • 00889024252905 ()

  • Femoral Speed Block .040, Size 4
6216-01-111

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
6216-01-110
In Commercial Distribution

  • 00889024252899 ()

  • Femoral Speed Block .040, Size 3
6216-01-110

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
6216-01-109
In Commercial Distribution

  • 00889024252882 ()

  • Femoral Speed Block .040, Size 2
6216-01-109

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
6216-01-108
In Commercial Distribution

  • 00889024252875 ()

  • Femoral Speed Block .040, Size 1
6216-01-108

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
6216-01-107
In Commercial Distribution

  • 00889024252868 ()

  • Femoral Speed Block .040, Size 0
6216-01-107

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
6216-01-106
In Commercial Distribution

  • 00889024252851 ()

  • Femoral Speed Block .040, Size 00
6216-01-106

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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
No Description
Biomet Orthopedics, LLC
32-347307
In Commercial Distribution

  • 00880304004382 ()
32-347307

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-347300
In Commercial Distribution

  • 00880304000414 ()
32-347300

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
X31-400058
In Commercial Distribution

  • 00880304183643 ()
X31-400058

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-347305
In Commercial Distribution

  • 00880304000667 ()
32-347305

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-488621
In Commercial Distribution

  • 00880304457225 ()
32-488621

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Biomet Orthopedics, LLC
32-488725
In Commercial Distribution

  • 00880304457218 ()

  • 40MM
32-488725

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-488724
In Commercial Distribution

  • 00880304457041 ()

  • 35MM
32-488724

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-487269
In Commercial Distribution

  • 00880304451742 ()
32-487269

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-488513
In Commercial Distribution

  • 00880304444300 ()
32-488513

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-484631
In Commercial Distribution

  • 00880304465527 ()
32-484631

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Biomet Orthopedics, LLC
32-484638
In Commercial Distribution

  • 00880304465497 ()
32-484638

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-484632
In Commercial Distribution

  • 00880304465480 ()
32-484632

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-484633
In Commercial Distribution

  • 00880304465473 ()
32-484633

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-484637
In Commercial Distribution

  • 00880304464902 ()
32-484637

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
31-112101
In Commercial Distribution

  • 00880304304222 ()
31-112101

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
31-109235
In Commercial Distribution

  • 00880304303836 ()
31-109235

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-484630
In Commercial Distribution

  • 00880304612327 ()
32-484630

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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