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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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No Description
G21 SRL
AR-902-1242M
In Commercial Distribution

  • 08058964728807 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-1042M
In Commercial Distribution

  • 08058964728777 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-0842M
In Commercial Distribution

  • 08058964728661 ()


  • Orthopaedic cement spacer mould
The SpaceFlex Acetabular Cup consists of disposable cement spacer molds indicated for use to mold a temporary Acetabular cup replacement for skeletally mature patients undergoing a two-stage procedure due to a septic process. The temporary prosthesis is molded using low viscosity antibiotic polymethylmethacrylate bone cement (G3A 40 bone cement) and positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The molded acetabular cup is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The molded temporary Acetabular cup prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.
G21 SRL
900203
In Commercial Distribution

  • 08058964727923 ()


  • Orthopaedic cement spacer mould
Orthopedic bone cement modular spacer for temporary knee prosthesis
G21 SRL
900189 80
In Commercial Distribution

  • 08058964727039 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
900189 70
In Commercial Distribution

  • 08058964726940 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
900189 60
In Commercial Distribution

  • 08058964726933 ()


  • Orthopaedic cement spacer mould
Disposable custom modular spacer mold
G21 SRL
900005 15
In Commercial Distribution

  • 08058964726902 ()


  • Orthopaedic cement spacer mould
Disposable custom modular spacer mold
G21 SRL
900005 13
In Commercial Distribution

  • 08058964726896 ()


  • Orthopaedic cement spacer mould
Disposable custom modular spacer mold
G21 SRL
900005 10
In Commercial Distribution

  • 08058964726889 ()


  • Orthopaedic cement spacer mould
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