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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TUKS, Femoral IM Drill Guide, 4.8mm X 51mm
Shalby Advanced Technologies, Inc.
3000-0-4801
In Commercial Distribution

  • 00840286847094 ()

  • Femoral IM Drill Guide, 4.8mm X 51mm
3000-0-4801

  • Surgical drill guide, reusable
Impactor, Tibial/Femoral, All Plastic, Small, Small Handle
Shalby Advanced Technologies, Inc.
2800-0-0705
In Commercial Distribution

  • 00840286843034 ()

  • Tibial/Femoral, All Plastic, Small, Small Handle
2800-0-0705

  • Orthopaedic implant impactor, reusable
RKS, Trial, Augment, Distal Femoral, Size 3/4
Shalby Advanced Technologies, Inc.
2979-0-0034
In Commercial Distribution

  • 00840286842945 ()

  • Trial, Augment, Distal Femoral, Size 3/4
2979-0-0034

  • Knee femur prosthesis trial, reusable
RKS, Trial, Augment, Distal Femoral, Size 5/6
Shalby Advanced Technologies, Inc.
2979-0-0056
In Commercial Distribution

  • 00840286842938 ()

  • Trial, Augment, Distal Femoral, Size 5/6
2979-0-0056

  • Knee femur prosthesis trial, reusable
RKS, Femoral AP Cutting Block, Right, Size 1
Shalby Advanced Technologies, Inc.
2982-0-0001
In Commercial Distribution

  • 00840286842372 ()

  • Femoral AP Cutting Block, Right, Size 1
2982-0-0001

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RKS, Femoral AP Cutting Block, Right, Size 2
Shalby Advanced Technologies, Inc.
2982-0-0002
In Commercial Distribution

  • 00840286842365 ()

  • Femoral AP Cutting Block, Right, Size 2
2982-0-0002

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RKS, Femoral AP Cutting Block, Right, Size 3
Shalby Advanced Technologies, Inc.
2982-0-0003
In Commercial Distribution

  • 00840286842358 ()

  • Femoral AP Cutting Block, Right, Size 3
2982-0-0003

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RKS, Femoral AP Cutting Block, Right, Size 4
Shalby Advanced Technologies, Inc.
2982-0-0004
In Commercial Distribution

  • 00840286842341 ()

  • Femoral AP Cutting Block, Right, Size 4
2982-0-0004

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RKS, Femoral AP Cutting Block, Right, Size 5
Shalby Advanced Technologies, Inc.
2982-0-0005
In Commercial Distribution

  • 00840286842334 ()

  • Femoral AP Cutting Block, Right, Size 5
2982-0-0005

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RKS, Femoral AP Cutting Block, Right, Size 6
Shalby Advanced Technologies, Inc.
2982-0-0006
In Commercial Distribution

  • 00840286842327 ()

  • Femoral AP Cutting Block, Right, Size 6
2982-0-0006

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RKS, Femoral AP Cutting Block, Left, Size 1
Shalby Advanced Technologies, Inc.
2981-0-0001
In Commercial Distribution

  • 00840286842242 ()

  • Femoral AP Cutting Block, Left, Size 1
2981-0-0001

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RKS, Femoral AP Cutting Block, Left, Size 2
Shalby Advanced Technologies, Inc.
2981-0-0002
In Commercial Distribution

  • 00840286842235 ()

  • Femoral AP Cutting Block, Left, Size 2
2981-0-0002

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RKS, Femoral AP Cutting Block, Left, Size 3
Shalby Advanced Technologies, Inc.
2981-0-0003
In Commercial Distribution

  • 00840286842228 ()

  • Femoral AP Cutting Block, Left, Size 3
2981-0-0003

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RKS, Femoral AP Cutting Block, Left, Size 4
Shalby Advanced Technologies, Inc.
2981-0-0004
In Commercial Distribution

  • 00840286842211 ()

  • Femoral AP Cutting Block, Left, Size 4
2981-0-0004

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RKS, Femoral AP Cutting Block, Left, Size 5
Shalby Advanced Technologies, Inc.
2981-0-0005
In Commercial Distribution

  • 00840286842204 ()

  • Femoral AP Cutting Block, Left, Size 5
2981-0-0005

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RKS, Femoral AP Cutting Block, Left, Size 6
Shalby Advanced Technologies, Inc.
2981-0-0006
In Commercial Distribution

  • 00840286842198 ()

  • Femoral AP Cutting Block, Left, Size 6
2981-0-0006

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Bipolar Femoral Head Trial, 22mm, Sz 56
Shalby Advanced Technologies, Inc.
1914-1-2256
In Commercial Distribution

  • 00840286841566 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 56
1914-1-2256

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 55
Shalby Advanced Technologies, Inc.
1914-1-2255
In Commercial Distribution

  • 00840286841559 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 55
1914-1-2255

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 54
Shalby Advanced Technologies, Inc.
1914-1-2254
In Commercial Distribution

  • 00840286841542 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 54
1914-1-2254

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 53
Shalby Advanced Technologies, Inc.
1914-1-2253
In Commercial Distribution

  • 00840286841535 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 53
1914-1-2253

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 52
Shalby Advanced Technologies, Inc.
1914-1-2252
In Commercial Distribution

  • 00840286841528 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 52
1914-1-2252

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 51
Shalby Advanced Technologies, Inc.
1914-1-2251
In Commercial Distribution

  • 00840286841511 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 51
1914-1-2251

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 50
Shalby Advanced Technologies, Inc.
1914-1-2250
In Commercial Distribution

  • 00840286841504 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 50
1914-1-2250

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 49
Shalby Advanced Technologies, Inc.
1914-1-2249
In Commercial Distribution

  • 00840286841498 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 49
1914-1-2249

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 48
Shalby Advanced Technologies, Inc.
1914-1-2248
In Commercial Distribution

  • 00840286841481 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 48
1914-1-2248

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 47
Shalby Advanced Technologies, Inc.
1914-1-2247
In Commercial Distribution

  • 00840286841474 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 47
1914-1-2247

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 46
Shalby Advanced Technologies, Inc.
1914-1-2246
In Commercial Distribution

  • 00840286841467 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 46
1914-1-2246

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 45
Shalby Advanced Technologies, Inc.
1914-1-2245
In Commercial Distribution

  • 00840286841450 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 45
1914-1-2245

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 44
Shalby Advanced Technologies, Inc.
1914-1-2244
In Commercial Distribution

  • 00840286841443 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 44
1914-1-2244

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 43
Shalby Advanced Technologies, Inc.
1914-1-2243
In Commercial Distribution

  • 00840286841436 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 43
1914-1-2243

  • Femoral head prosthesis trial
Bipolar Femoral Head Trial, 22mm, Sz 42
Shalby Advanced Technologies, Inc.
1914-1-2242
In Commercial Distribution

  • 00840286841429 ()

  • Bipolar Femoral Head Trial, 22mm, Sz 42
1914-1-2242

  • Femoral head prosthesis trial
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
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
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