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
431209
In Commercial Distribution

  • 00880304447141 ()

  • 9X125 MM 51 MM
431209

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

  • 00880304551015 ()

  • 8 MM 46X18X53 MM STANDARD LENGTH
431408

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

  • 00880304551114 ()

  • 14 MM 58X24X64 MM STANDARD LENGTH
431414

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

  • 00880304551107 ()

  • 6 MM 42X18X46 MM STANDARD LENGTH
431406

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

  • 00880304551091 ()

  • 10 MM 50X21X57 MM STANDARD LENGTH
431410

  • Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431412
In Commercial Distribution

  • 00880304551008 ()

  • 12 MM 54X21X64 MM STANDARD LENGTH
431412

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

  • 08058964729149 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AS-902-1242M
In Commercial Distribution

  • 08058964729132 ()


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

  • 08058964729125 ()


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

  • 08058964729118 ()


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

  • 08058964729095 ()


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

  • 08058964729088 ()


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

  • 08058964728975 ()


  • Orthopaedic cement spacer mould
No Description
G21 SRL
AR-902-10
In Commercial Distribution

  • 08058964728968 ()


  • 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
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
The Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS9213K-10
In Commercial Distribution

  • 00816125026142 ()
ZS9213K-10

  • Orthopaedic cement spacer mould
The CemSyntek Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS9213K-5
In Commercial Distribution

  • 00816125026135 ()
ZS9213K-5

  • Orthopaedic cement spacer mould
The CemSyntek Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS9213K-2
In Commercial Distribution

  • 00816125026128 ()
ZS9213K-2

  • Orthopaedic cement spacer mould
The Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
BERKELEY ADVANCED BIOMATERIALS, LLC
PCK-02
In Commercial Distribution

  • 00816125024353 ()
PCK-02

  • 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
No Description
G21 SRL
900012
In Commercial Distribution

  • 08058964726797 ()


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

  • 08058964727039 ()


  • 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 104818
In Commercial Distribution

  • 08058964726056 ()


  • 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
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