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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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SELF DRILLING CORTICAL SCREW L60/20MM D3.0-2.5MM PACK OF 2 STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18052469470794 ()

  • Outer Diameter: 3 Millimeter
  • Length: 60 Millimeter
99-M311M

  • Orthopaedic bone pin, non-bioabsorbable
External fixation system for dorsal fracture dislocations of the PIP joint.
Hand Biomechanics Lab Inc
PFX-426
In Commercial Distribution

  • 00861994000243 ()
PFX-426

  • Orthopaedic bone pin, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
XL-115366
In Commercial Distribution

  • 00880304475458 ()

  • 44MM Ø 41MM Ø OF CURV STANDARD
XL-115366

  • Polyethylene reverse shoulder prosthesis cup
No Description
Biomet Orthopedics, LLC
XL-115363
In Commercial Distribution

  • 00880304475427 ()

  • 44MM Ø 36MM Ø OF CURV STANDARD
XL-115363

  • Polyethylene reverse shoulder prosthesis cup
No Description
Biomet Orthopedics, LLC
EP-115396
In Commercial Distribution

  • 00880304543164 ()

  • 44MM Ø 41MM Ø OF CURV STANDARD
EP-115396

  • Polyethylene reverse shoulder prosthesis cup
No Description
Biomet Orthopedics, LLC
EP-115393
In Commercial Distribution

  • 00880304543157 ()

  • 44MM Ø 36MM Ø OF CURV STANDARD
EP-115393

  • Polyethylene reverse shoulder prosthesis cup
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
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