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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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Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip 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 Hip 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
SPC0122
In Commercial Distribution

  • 28031497000620 ()

  • Length: 94 Millimeter
  • diameter of the femoral head: 54 mm


  • Orthopaedic cement spacer
Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip 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 Hip 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
SPC0022
In Commercial Distribution

  • 28031497000613 ()

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


  • Orthopaedic cement spacer
JPS SS 3.5MM PROXIMAL FEMUR PLATE 90° - 3 HOLES 12MM OFFSET STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800896013 ()

  • Lumen/Inner Diameter: 3.5 Millimeter
  • Nr of holes: 3
  • Offset: 12 Millimeter
99-5431005

  • Orthopaedic fixation plate, non-bioabsorbable
JPS SS 3.5MM PROXIMAL FEMUR PLATE 90° - 3 HOLES 6MM OFFSET STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800896006 ()

  • Lumen/Inner Diameter: 3.5 Millimeter
  • Nr of holes: 3
  • Offset: 6 Millimeter
99-5431004

  • Orthopaedic fixation plate, non-bioabsorbable
JPS SS 3.0MM PROXIMAL FEMUR PLATE 110° - 3 HOLES 6MM OFFSET STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800895986 ()

  • Lumen/Inner Diameter: 3.0 Millimeter
  • Nr of holes: 3
  • Offset: 6 Millimeter
99-5431002

  • Orthopaedic fixation plate, non-bioabsorbable
JPS SS 3.0MM PROXIMAL FEMUR PLATE 90° - 3 HOLES 6MM OFFSET STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800895979 ()

  • Lumen/Inner Diameter: 3.0 Millimeter
  • Nr of holes: 3
  • Offset: 6 Millimeter
99-5431001

  • Orthopaedic fixation plate, non-bioabsorbable
JPS SS 5.0MM PROXIMAL FEMUR PLATE 120° - 4 HOLES 14MM OFFSET STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800896259 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
  • Nr of holes: 4
  • Offset: 14 Millimeter
99-5431029

  • Orthopaedic fixation plate, non-bioabsorbable
JPS SS 5.0MM PROXIMAL FEMUR PLATE 120° - 4 HOLES 6MM OFFSET STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800896242 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
  • Nr of holes: 4
  • Offset: 6 Millimeter
99-5431028

  • Orthopaedic fixation plate, non-bioabsorbable
JPS SS 5.0MM PROXIMAL FEMUR PLATE 110° - 4 HOLES 14MM OFFSET STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800896235 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
  • Nr of holes: 4
  • Offset: 14 Millimeter
99-5431027

  • Orthopaedic fixation plate, non-bioabsorbable
JPS SS 5.0MM PROXIMAL FEMUR PLATE 110° - 4 HOLES 6MM OFFSET STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800896228 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
  • Nr of holes: 4
  • Offset: 6 Millimeter
99-5431026

  • Orthopaedic fixation plate, non-bioabsorbable
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