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
Biomet Orthopedics, LLC
431193
In Commercial Distribution

  • 00880304521179 ()

  • 15 mm 155 mm
431193

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431199
In Commercial Distribution

  • 00880304521162 ()

  • 17 MM 200 MM
431199

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431194
In Commercial Distribution

  • 00880304521155 ()

  • 17 mm 165 mm
431194

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431197
In Commercial Distribution

  • 00880304521148 ()

  • 13 mm 200 mm
431197

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431198
In Commercial Distribution

  • 00880304521131 ()

  • 15 mm 200 mm
431198

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431195
In Commercial Distribution

  • 00880304521124 ()

  • 9 mm 200 mm
431195

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431196
In Commercial Distribution

  • 00880304521117 ()

  • 11 mm 200 mm
431196

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431181
In Commercial Distribution

  • 00880304521100 ()

  • 48 mm
431181

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431185
In Commercial Distribution

  • 00880304521063 ()

  • 64 mm
431185

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431184
In Commercial Distribution

  • 00880304521056 ()

  • 60 mm
431184

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431182
In Commercial Distribution

  • 00880304521032 ()

  • 52 mm
431182

  • Orthopaedic cement spacer mould
TIBIAL SPACER MOLD LARGE
Ortho Development Corporation
SST2081
In Commercial Distribution

  • 00822409043231 ()

  • Length: 52 Millimeter
  • Width: 81 Millimeter


  • Orthopaedic cement spacer mould
TIBIAL SPACER MOLD MEDIUM
Ortho Development Corporation
SST2070
In Commercial Distribution

  • 00822409043224 ()

  • Width: 70 Millimeter
  • Length: 45 Millimeter


  • Orthopaedic cement spacer mould
TIBIAL SPACER MOLD SMALL
Ortho Development Corporation
SST2058
In Commercial Distribution

  • 00822409043217 ()

  • Width: 58 Millimeter
  • Length: 39 Millimeter


  • Orthopaedic cement spacer mould
FEMORAL SPACER MOLD LARGE
Ortho Development Corporation
SSF1075
In Commercial Distribution

  • 00822409043200 ()

  • Width: 75 Millimeter
  • Length: 53 Millimeter


  • Orthopaedic cement spacer mould
FEMORAL SPACER MOLD MEDIUM
Ortho Development Corporation
SSF1067
In Commercial Distribution

  • 00822409043194 ()

  • Length: 44 Millimeter
  • Width: 67 Millimeter


  • Orthopaedic cement spacer mould
FEMORAL SPACER MOLD SMALL
Ortho Development Corporation
SSF1060
In Commercial Distribution

  • 00822409043187 ()

  • Width: 60 Millimeter
  • Length: 37 Millimeter


  • 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 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
SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFlex Hip to mold temporary prosthesis.
G21 SRL
900008
Not in Commercial Distribution

  • 08058964726186 ()


  • Orthopaedic cement spacer mould
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period. The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.
G21 SRL
900001 084215
In Commercial Distribution

  • 08058964724977 ()


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

  • 08058964726940 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
900012
In Commercial Distribution

  • 08058964726797 ()


  • Orthopaedic cement spacer mould
"Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period. The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge."
G21 SRL
900001 144818
In Commercial Distribution

  • 08058964726087 ()


  • Orthopaedic cement spacer mould
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period. The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.
G21 SRL
900001 124818
In Commercial Distribution

  • 08058964726070 ()


  • Orthopaedic cement spacer mould
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period. The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.
G21 SRL
900001 124215
In Commercial Distribution

  • 08058964726063 ()


  • Orthopaedic cement spacer mould
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period. The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.
G21 SRL
900001 104818
In Commercial Distribution

  • 08058964726056 ()


  • Orthopaedic cement spacer mould
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period. The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.
G21 SRL
900001 104215
In Commercial Distribution

  • 08058964726049 ()


  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
433180
In Commercial Distribution

  • 00887868543302 ()

  • M/L 80mm A/P 48mm
433180

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
433175
In Commercial Distribution

  • 00887868543296 ()

  • M/L 75mm A/P 45mm
433175

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
433170
In Commercial Distribution

  • 00887868543289 ()

  • M/L 70mm A/P 42mm
433170

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
432175
In Commercial Distribution

  • 00887868543265 ()

  • M/L 75mm A/P 57mm
432175

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
432165
In Commercial Distribution

  • 00887868543241 ()

  • M/L 65mm A/P 48mm
432165

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431414
In Commercial Distribution

  • 00887868543227 ()

  • Ø14mm Stem Ø64mm Head 58mm Head Width 24mm Head Thickness
431414

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431410
In Commercial Distribution

  • 00887868543203 ()

  • Ø10mm Stem Ø57mm Head 50mm Head Width 21mm Head Thickness
431410

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431408
In Commercial Distribution

  • 00887868543197 ()

  • Ø8mm Stem Ø53mm Head 46mm Head Width 18mm Head Thickness
431408

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431406
In Commercial Distribution

  • 00887868543180 ()

  • Ø6mm Stem Ø46mm Head 42mm Head Width 18mm Head Thickness
431406

  • Orthopaedic cement spacer mould
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