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TECRES SPA SPC0423 Interspace Tapered Wedge Stem

Company Name
TECRES SPA
Catalog Number
SPC0423
Device Size
  • Length: 209.2 Millimeter
  • diameter of femoral head: 54 mm

Description

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.).
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Additional Details

Device Identifier
08031497001623
Is RX
Yes
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
Yes
Is Single Use
Yes

Barcode Mapping

Unit of MeasurementEachesGTIN
Each108031497001623