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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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joimax® Vitegra® DICOM module
Joimax GmbH
ICS0401D
In Commercial Distribution

  • 04250337119685 ()

  • License key for enabling the DICOM functionality
ICS0401D

  • Medical image management system
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
SPC0323
In Commercial Distribution

  • 08031497001616 ()

  • Length: 211 Millimeter
  • diameter of the femoral head: 46 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
SPC0223
In Commercial Distribution

  • 08031497001609 ()

  • Length: 95.8 Millimeter
  • diameter of the 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
SPC0123
In Commercial Distribution

  • 08031497001593 ()

  • Length: 94.3 Millimeter
  • diameter of the femoral head: 54 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
SPC0023
In Commercial Distribution

  • 08031497001586 ()

  • Length: 96 Millimeter
  • diameter of the femoral head: 46 mm


  • Orthopaedic cement spacer
No Description
Zimmer, Inc.
5970-50-09
In Commercial Distribution

  • 00889024214477 ()

  • Size Blue, (5.5 mm Under the Condyles)
  • Height: 9 Millimeter
00-5970-050-09

  • Tibial insert
No Description
Zimmer, Inc.
5970-40-09
In Commercial Distribution

  • 00889024214392 ()

  • Size Green, (5.5 mm Under the Condyles)
  • Height: 9 Millimeter
00-5970-040-09

  • Tibial insert
No Description
Zimmer, Inc.
5970-30-09
In Commercial Distribution

  • 00889024214316 ()

  • Size Yellow, (5.5 mm Under the Condyles)
  • Height: 9 Millimeter
00-5970-030-09

  • Tibial insert
No Description
Zimmer, Inc.
00-5916-070-09
In Commercial Distribution

  • 00889024000445 ()

  • Size G, (5.5 mm Under the Condyles)


  • Tibial insert
No Description
Zimmer, Inc.
00-5916-060-09
In Commercial Distribution

  • 00889024000360 ()

  • Size F, (5.5 mm Under the Condyles)


  • Tibial insert
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