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-902-10
In Commercial Distribution

  • 08058964728968 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-09
In Commercial Distribution

  • 08058964728951 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-08
In Commercial Distribution

  • 08058964728944 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-07
In Commercial Distribution

  • 08058964728937 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-06
In Commercial Distribution

  • 08058964728920 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-05
In Commercial Distribution

  • 08058964728913 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-04
In Commercial Distribution

  • 08058964728906 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-03
In Commercial Distribution

  • 08058964728890 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-02
In Commercial Distribution

  • 08058964728883 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-01
In Commercial Distribution

  • 08058964728876 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-1048M
In Commercial Distribution

  • 08058964728869 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-1448M
In Commercial Distribution

  • 08058964728821 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-1248M
In Commercial Distribution

  • 08058964728814 ()


  • 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
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 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
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
Medium 44A/P x 67M/L Femoral Spacer Mold
Ortho Development Corporation
669-1067
In Commercial Distribution

  • 00822409007561 ()

  • Width: 67 Millimeter
  • Length: 44 Millimeter


  • Orthopaedic cement spacer mould
Small 37A/P x 60M/L Femoral Spacer Mold
Ortho Development Corporation
669-1060
In Commercial Distribution

  • 00822409007554 ()

  • Length: 37 Millimeter
  • Width: 60 Millimeter


  • Orthopaedic cement spacer mould
Large 52A/P x 81M/L Tibial Spacer Mold
Ortho Development Corporation
669-2081
In Commercial Distribution

  • 00822409007608 ()

  • Length: 52 Millimeter
  • Width: 81 Millimeter


  • Orthopaedic cement spacer mould
Medium 45A/P x 70M/L Tibial Spacer Mold
Ortho Development Corporation
669-2070
In Commercial Distribution

  • 00822409007592 ()

  • Width: 70 Millimeter
  • Length: 45 Millimeter


  • Orthopaedic cement spacer mould
Small 39A/P x 58M/L Tibial Spacer Mold
Ortho Development Corporation
669-2058
In Commercial Distribution

  • 00822409007585 ()

  • Width: 58 Millimeter
  • Length: 39 Millimeter


  • Orthopaedic cement spacer mould
Large 53A/P x 75M/L Femoral Spacer Mold
Ortho Development Corporation
669-1075
In Commercial Distribution

  • 00822409007578 ()

  • Width: 75 Millimeter
  • Length: 53 Millimeter


  • 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
COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision. COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented. COPAL® knee moulds are intended for single use and must not be re-used or resterilised.
Heraeus Medical GmbH
L
In Commercial Distribution

  • 04260102139299 ()
  • 04260102139305 ()
  • 04260102139312 ()
5159870

  • Orthopaedic cement spacer mould
COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision. COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented. COPAL® knee moulds are intended for single use and must not be re-used or resterilised.
Heraeus Medical GmbH
M
In Commercial Distribution

  • 04260102139275 ()
  • 04260102139268 ()
  • 04260102139282 ()
5159869

  • Orthopaedic cement spacer mould
COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision. COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented COPAL® knee moulds are intended for single use and must not be re-used or resterilised.
Heraeus Medical GmbH
S
In Commercial Distribution

  • 04260102139244 ()
  • 04260102139237 ()
  • 04260102139251 ()
5159868

  • 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
433165
In Commercial Distribution

  • 00887868543272 ()

  • M/L 65mm A/P 39mm
433165

  • 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
432170
In Commercial Distribution

  • 00887868543258 ()

  • M/L 70mm A/P 52mm
432170

  • 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
432160
In Commercial Distribution

  • 00887868543234 ()

  • M/L 60mm A/P 43mm
432160

  • 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
431412
In Commercial Distribution

  • 00887868543210 ()

  • Ø12mm Stem Ø64mm Head 54mm Head Width 21mm Head Thickness
431412

  • 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
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