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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Bipolar Femoral Head Trial, 22mm, Sz 41
Shalby Advanced Technologies, Inc.
1914-1-2241
In Commercial Distribution

  • 00840286841412 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 41
1914-1-2241

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 40
Shalby Advanced Technologies, Inc.
1914-1-2240
In Commercial Distribution

  • 00840286841405 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 40
1914-1-2240

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 39
Shalby Advanced Technologies, Inc.
1914-1-2239
In Commercial Distribution

  • 00840286841399 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 39
1914-1-2239

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 38
Shalby Advanced Technologies, Inc.
1914-1-2238
In Commercial Distribution

  • 00840286841382 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 38
1914-1-2238

  • Femoral head prosthesis trial
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.).
TECRES SPA
SPC0323
In Commercial Distribution

  • 08031497001616 ()

  • Length: 211 Millimeter
  • diameter of the femoral head: 46 mm


  • Orthopaedic cement spacer
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.).
TECRES SPA
SPC0223
In Commercial Distribution

  • 08031497001609 ()

  • Length: 95.8 Millimeter
  • diameter of the femoral head: 60 mm


  • Orthopaedic cement spacer
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.).
TECRES SPA
SPC0123
In Commercial Distribution

  • 08031497001593 ()

  • Length: 94.3 Millimeter
  • diameter of the femoral head: 54 mm


  • Orthopaedic cement spacer
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.).
TECRES SPA
SPC0023
In Commercial Distribution

  • 08031497001586 ()

  • Length: 96 Millimeter
  • diameter of the femoral head: 46 mm


  • Orthopaedic cement spacer
36mm Femoral Head Trial, Blue, +7mm offset
TOTAL JOINT ORTHOPEDICS, INC.
1306.36.700
In Commercial Distribution

  • 00819251021180 ()

  • 36mm Femoral Head Trial, Blue, +7mm offset


  • Femoral head prosthesis trial
36mm Femoral Head Trial, Blue, +0mm offset
TOTAL JOINT ORTHOPEDICS, INC.
1306.36.000
In Commercial Distribution

  • 00819251021166 ()

  • 36mm Femoral Head Trial, Blue, +0mm offset


  • Femoral head prosthesis trial
36mm Femoral Head Trial, Blue, -3.5mm offset
TOTAL JOINT ORTHOPEDICS, INC.
1306.36.035
In Commercial Distribution

  • 00819251021159 ()

  • 36mm Femoral Head Trial, Blue, -3.5mm offset


  • Femoral head prosthesis trial
32mm Femoral Head Trial, Green, +3.5mm offset
TOTAL JOINT ORTHOPEDICS, INC.
1306.32.350
In Commercial Distribution

  • 00819251021135 ()

  • 32mm Femoral Head Trial, Green, +3.5mm offset


  • Femoral head prosthesis trial
32mm Femoral Head Trial, Green, -3.5mm offset
TOTAL JOINT ORTHOPEDICS, INC.
1306.32.035
In Commercial Distribution

  • 00819251021111 ()

  • 32mm Femoral Head Trial, Green, -3.5mm offset


  • Femoral head prosthesis trial
36mm Femoral Head Trial, Blue, +3.5mm offset
TOTAL JOINT ORTHOPEDICS, INC.
1306.36.350
In Commercial Distribution

  • 00819251021173 ()

  • 36mm Femoral Head Trial, Blue, +3.5mm offset


  • Femoral head prosthesis trial
32mm Femoral Head Trial, Green, +7mm offset
TOTAL JOINT ORTHOPEDICS, INC.
1306.32.700
In Commercial Distribution

  • 00819251021142 ()

  • 32mm Femoral Head Trial, Green, +7mm offset


  • Femoral head prosthesis trial
32mm Femoral Head Trial, Green, +0mm offset
TOTAL JOINT ORTHOPEDICS, INC.
1306.32.000
In Commercial Distribution

  • 00819251021128 ()

  • 32mm Femoral Head Trial, Green, +0mm offset


  • Femoral head prosthesis trial
Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip 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 Hip 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.).
TECRES SPA
SPC0522
In Commercial Distribution

  • 28031497000668 ()

  • Length: 211 Millimeter
  • diameter of the femoral head: 60 mm


  • Orthopaedic cement spacer
Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip 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 Hip 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.).
TECRES SPA
SPC0422
In Commercial Distribution

  • 28031497000651 ()

  • Length: 209 Millimeter
  • diameter of the femoral head: 54 mm


  • Orthopaedic cement spacer
Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip 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 Hip 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.).
TECRES SPA
SPC0322
In Commercial Distribution

  • 28031497000644 ()

  • Length: 211 Millimeter
  • dimater of the femoral head: 46 mm


  • Orthopaedic cement spacer
Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip 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 Hip 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.).
TECRES SPA
SPC0122
In Commercial Distribution

  • 28031497000620 ()

  • Length: 94 Millimeter
  • diameter of the femoral head: 54 mm


  • Orthopaedic cement spacer
Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip 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 Hip 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.).
TECRES SPA
SPC0022
In Commercial Distribution

  • 28031497000613 ()

  • Length: 96 Millimeter
  • diameter of the femoral head 46 mm


  • Orthopaedic cement spacer
Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip 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 Hip 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.).
TECRES SPA
SPC0222
In Commercial Distribution

  • 28031497000637 ()

  • Length: 98 Millimeter
  • diameter of the femoral head: 60 mm


  • Orthopaedic cement spacer
No Description
Biomet Orthopedics, LLC
CP112964
In Commercial Distribution

  • 00880304653146 ()

  • 60 MM
CP112964

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
CP112962
In Commercial Distribution

  • 00880304653122 ()

  • 54 mm
CP112962

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
CP112960
In Commercial Distribution

  • 00880304653108 ()

  • 51 mm
CP112960

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
CP112959
In Commercial Distribution

  • 00880304653092 ()

  • 48 MM
CP112959

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
CP112958
In Commercial Distribution

  • 00880304653085 ()

  • 48 MM
CP112958

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
CP112956
In Commercial Distribution

  • 00880304653061 ()

  • 45 MM
CP112956

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
CP112954
In Commercial Distribution

  • 00880304653047 ()

  • 42 MM
CP112954

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
CP112965
In Commercial Distribution

  • 00880304653153 ()

  • 60 mm
CP112965

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
CP112963
In Commercial Distribution

  • 00880304653139 ()

  • 54 mm
CP112963

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
CP112961
In Commercial Distribution

  • 00880304653115 ()

  • 51 MM
CP112961

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
CP112955
In Commercial Distribution

  • 00880304653054 ()

  • 42 MM
CP112955

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
149037
In Commercial Distribution

  • 00880304236905 ()

  • 17 MM 2.5 MM
149037

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
149035
In Commercial Distribution

  • 00880304236899 ()

  • 15 MM 2.5 MM
149035

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
149022
In Commercial Distribution

  • 00880304236790 ()

  • 12 MM 1.5 MM
149022

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
149019
In Commercial Distribution

  • 00880304236769 ()

  • 9 MM 1.5 MM
149019

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
149033
In Commercial Distribution

  • 00880304236875 ()

  • 13 MM 2.5 MM
149033

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
149031
In Commercial Distribution

  • 00880304236851 ()

  • 11 MM 2.5 MM
149031

  • Femoral stem centralizer
No Description
Biomet Orthopedics, LLC
149029
In Commercial Distribution

  • 00880304236844 ()

  • 9 MM 2.5 MM
149029

  • Femoral stem centralizer
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