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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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
ASSY, Bipolar Insert And Filler Ring
CONSENSUS ORTHOPEDICS, INC.
86-1015-0-5456
Not in Commercial Distribution

  • 00840341102298 ()

  • Outer Diameter: 28 Millimeter
86-1015-0-5456

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Insert And Filler Ring
CONSENSUS ORTHOPEDICS, INC.
86-1015-0-5153
Not in Commercial Distribution

  • 00840341102281 ()

  • Outer Diameter: 28 Millimeter
86-1015-0-5153

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Insert And Filler Ring
CONSENSUS ORTHOPEDICS, INC.
86-1018-0-4547
Not in Commercial Distribution

  • 00840341102274 ()

  • Outer Diameter: 22 Millimeter
86-1018-0-4547

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Insert And Filler Ring
CONSENSUS ORTHOPEDICS, INC.
86-1018-0-4244
Not in Commercial Distribution

  • 00840341102267 ()

  • Outer Diameter: 22 Millimeter
86-1018-0-4244

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Femoral Head-Locking Ring
CONSENSUS ORTHOPEDICS, INC.
86-1014-0-0056
Not in Commercial Distribution

  • 00840341102250 ()

  • Outer Diameter: 56 Millimeter
86-1014-0-0056

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Femoral Head-Locking Ring
CONSENSUS ORTHOPEDICS, INC.
86-1014-0-0054
Not in Commercial Distribution

  • 00840341102243 ()

  • Outer Diameter: 54 Millimeter
86-1014-0-0054

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Femoral Head-Locking Ring
CONSENSUS ORTHOPEDICS, INC.
86-1014-0-0052
Not in Commercial Distribution

  • 00840341102236 ()

  • Outer Diameter: 52 Millimeter
86-1014-0-0052

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Femoral Head-Locking Ring
CONSENSUS ORTHOPEDICS, INC.
86-1014-0-0050
Not in Commercial Distribution

  • 00840341102229 ()

  • Outer Diameter: 50 Millimeter
86-1014-0-0050

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Femoral Head-Locking Ring
CONSENSUS ORTHOPEDICS, INC.
86-1014-0-0048
Not in Commercial Distribution

  • 00840341102212 ()

  • Outer Diameter: 48 Millimeter
86-1014-0-0048

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Femoral Head-Locking Ring
CONSENSUS ORTHOPEDICS, INC.
86-1014-0-0046
Not in Commercial Distribution

  • 00840341102205 ()

  • Outer Diameter: 46 Millimeter
86-1014-0-0046

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Femoral Head-Locking Ring
CONSENSUS ORTHOPEDICS, INC.
86-1014-0-0044
Not in Commercial Distribution

  • 00840341102199 ()

  • Outer Diameter: 44 Millimeter
86-1014-0-0044

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Femoral Head-Locking Ring
CONSENSUS ORTHOPEDICS, INC.
86-1014-0-0042
Not in Commercial Distribution

  • 00840341102182 ()

  • Outer Diameter: 42 Millimeter
86-1014-0-0042

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Femoral Head-Locking Ring
CONSENSUS ORTHOPEDICS, INC.
86-1014-0-0040
Not in Commercial Distribution

  • 00840341102175 ()

  • Outer Diameter: 40 Millimeter
86-1014-0-0040

  • Bipolar femoral head outer component, hemiarthroplasty
ASSY, Bipolar Femoral Head-Locking Ring
CONSENSUS ORTHOPEDICS, INC.
86-1014-0-0038
Not in Commercial Distribution

  • 00840341102168 ()

  • Outer Diameter: 38 Millimeter
86-1014-0-0038

  • Bipolar femoral head outer component, hemiarthroplasty
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
0234-109-240
In Commercial Distribution

  • 10818674022450 ()
148400st

  • Orthopaedic guidewire, reusable
No Description
SOC ETUDES RECHERCHES FABRICATION
D28-CL
In Commercial Distribution

RM30660003

  • Ceramic femoral head prosthesis
No Description
SOC ETUDES RECHERCHES FABRICATION
D28-CM
In Commercial Distribution

RM30660002

  • Ceramic femoral head prosthesis
No Description
SOC ETUDES RECHERCHES FABRICATION
D28-CC
In Commercial Distribution

RM30660001

  • Ceramic femoral head prosthesis
No Description
SOC ETUDES RECHERCHES FABRICATION
C28-CL
In Commercial Distribution

  • 03662200024384 ()


  • Metallic femoral head prosthesis
No Description
SOC ETUDES RECHERCHES FABRICATION
C28-CM
In Commercial Distribution

  • 03662200024377 ()


  • Metallic femoral head prosthesis
No Description
SOC ETUDES RECHERCHES FABRICATION
C28-CC
In Commercial Distribution

  • 03662200024360 ()


  • Metallic femoral head prosthesis
No Description
SOC ETUDES RECHERCHES FABRICATION
C22.2-CL
In Commercial Distribution

  • 03662200024353 ()


  • Metallic femoral head prosthesis
No Description
SOC ETUDES RECHERCHES FABRICATION
C22.2-CM
In Commercial Distribution

  • 03662200024346 ()


  • Metallic femoral head prosthesis
No Description
SOC ETUDES RECHERCHES FABRICATION
C22.2-CC
In Commercial Distribution

  • 03662200024339 ()


  • Metallic femoral head prosthesis
No Description
SOC ETUDES RECHERCHES FABRICATION
D28-CL
Not in Commercial Distribution

  • 03662200004126 ()


  • Ceramic femoral head prosthesis
No Description
SOC ETUDES RECHERCHES FABRICATION
D28-CM
Not in Commercial Distribution

  • 03662200004119 ()


  • Ceramic femoral head prosthesis
No Description
SOC ETUDES RECHERCHES FABRICATION
D28-CC
Not in Commercial Distribution

  • 03662200004102 ()


  • Ceramic femoral head prosthesis
Paxeon Head 40mm, CoCr Size XL
PAXEON RECONSTRUCTION LLC
PR111-152-044
In Commercial Distribution

  • 08177570200290 ()


  • Metallic femoral head prosthesis
Paxeon Head 40mm, CoCr Size L
PAXEON RECONSTRUCTION LLC
PR111-152-043
In Commercial Distribution

  • 08177570200283 ()


  • Metallic femoral head prosthesis
Paxeon Head 40mm, CoCr Size M
PAXEON RECONSTRUCTION LLC
PR111-152-042
In Commercial Distribution

  • 08177570200276 ()


  • Metallic femoral head prosthesis
Paxeon Head 40mm, CoCr Size S
PAXEON RECONSTRUCTION LLC
PR111-152-041
In Commercial Distribution

  • 08177570200269 ()


  • Metallic femoral head prosthesis
Paxeon Head, Ceramic Size 40mm XL
PAXEON RECONSTRUCTION LLC
PR111-152-644
In Commercial Distribution

  • 08177570200252 ()


  • Ceramic femoral head prosthesis
Paxeon Head, Ceramic Size 40mm L
PAXEON RECONSTRUCTION LLC
PR111-152-643
In Commercial Distribution

  • 08177570200245 ()


  • Ceramic femoral head prosthesis
Paxeon Head, Ceramic Size 40mm M
PAXEON RECONSTRUCTION LLC
PR111-152-642
In Commercial Distribution

  • 08177570200238 ()


  • Ceramic femoral head prosthesis
Paxeon Head, Ceramic Size 40mm S
PAXEON RECONSTRUCTION LLC
PR111-152-641
In Commercial Distribution

  • 08177570200221 ()


  • Ceramic femoral head prosthesis
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