InterSpace Knee Extra-Large Size, InterSpace Knee ATS
Tecres SpA
TECRES SPA
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9614841 | 3002808402 | TECRES SPA | 1 | N | 2026-01-01 | VIA ANDREA DORIA 6 SOMMACAMPAGNA VERONA Veneto IT 37066 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 54740 | 1932844587 | K252326 | InterSpace GV Hip Spacer | KWL | 2025-08-06 |
| 54740 | 1252262637 | K223709 | Kyphoplasty Balloon Catheter | HRX | 2023-08-16 |
| 54740 | 1002062983 | K220131 | KYPHON VuE Bone Cement | NDN | 2022-04-18 |
| 54740 | 1555928463 | K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATS | JWH | 2019-04-27 |
| 54740 | 1586800778 | K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System | LOD | 2015-03-05 |
| 54740 | 1631618481 | K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta | LOD | 2015-03-05 |
| 54740 | 1537861935 | K122175 | MENDEC SPINE HV, MENDEC SPINE HV SYSTEM | NDN | 2013-03-28 |
| 54740 | 1892755726 | K112983 | SPACER-S | HSD | 2011-12-12 |
| 54740 | 1059928574 | K101356 | Spacer-G and Spacer-K | KWL | 2011-09-20 |
| 54740 | 1925710742 | K092773 | CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST | LOD | 2009-11-24 |
| 54740 | 1555108979 | K062452 | KIT MENDEC SPINE AND DELIVERY SYSTEM | NDN | 2006-09-21 |
| 54740 | 1392304881 | K053189 | COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES | JDC | 2005-12-09 |
| 54740 | 1162793550 | K042415 | MENDEC SPINE | NDN | 2005-06-09 |
| 54740 | 1352849673 | K031430 | CEMEX SYSTEM FAST | LOD | 2003-05-22 |
| 54740 | 1093705987 | K021765 | CEMENT RESTRICTOR, SMALL AND LARGE | JDK | 2002-08-16 |
| 54740 | 1993030934 | K021715 | CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL | LOD | 2002-06-12 |
| 54740 | 1238257084 | K000943 | CEMEX SYSTEM GUN APPLICATION VERSION | LOD | 2001-02-08 |
| 54740 | 1008655600 | ||||
| 54740 | 1184095498 | ||||
| 54740 | 1255885211 | ||||
| 54740 | 1698726865 | ||||
| 54740 | 1041139214 | ||||
| 54740 | 1072066950 | ||||
| 54740 | 1116336343 | ||||
| 54740 | 1178203209 | ||||
| 54740 | 1183199514 | ||||
| 54740 | 1260748699 | ||||
| 54740 | 1440121337 | ||||
| 54740 | 1476317933 | ||||
| 54740 | 1511843316 | ||||
| 54740 | 1516547943 | ||||
| 54740 | 1650540195 | ||||
| 54740 | 1704027841 | ||||
| 54740 | 1717810141 | ||||
| 54740 | 1762848037 | ||||
| 54740 | 1816101735 | ||||
| 54740 | 1816381531 | ||||
| 54740 | 1868962470 | ||||
| 54740 | 1892076979 | ||||
| 54740 | 1995825329 | ||||
| 54740 | 1996940278 | ||||
| 54740 | 2017306400 |
Product Codes Associated With Registrations#
PMN#
MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
TECRES SPA
SPACER-S
TECRES SPA
SPACER-K, SPACER-G, SPACER-S
TECRES SPA
CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST
TECRES SPA
SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321
TECRES SPA
SPACER-G TEMPORARY HIP PROSTHESIS
TECRES SPA
KIT MENDEC SPINE AND DELIVERY SYSTEM
TECRES SPA
SPACER-S TEMPORARY SHOULDER SPACER
TECRES SPA
MENDEC SPINE
TECRES SPA
GUDID#
InterSpace Hip Trial, 46mm Short - IHT46S
2026-02-11
InterSpace Hip Trial, 54mm Short - IHT54S
2026-02-11
InterSpace Hip Trial, 60mm Short - IHT60S
2026-02-11
InterSpace Hip Trial, 46mm Long - IHT46L
2026-02-11
InterSpace Hip Trial, 54mm Long - IHT54L
2026-02-11
InterSpace Hip Trial, 60mm Long - IHT60L
2026-02-11
Interspace GV Hip Spacer 46 - TAPERED WEDGE STEM
2026-02-11
Interspace GV Hip Spacer 54 - TAPERED WEDGE STEM
2026-02-11
Interspace GV Hip Spacer 60 - TAPERED WEDGE STEM
2026-02-11
Interspace GV Hip Spacer 46 XL - TAPERED WEDGE STEM
2026-02-11
Interspace GV Hip Spacer 54 XL - TAPERED WEDGE STEM
2026-02-11
Interspace GV Hip Spacer 60 XL - TAPERED WEDGE STEM
2026-02-11
InterSpace Knee Trial - InterSpace Knee Trial is intended to be used for the selection of the right size of InterSpace Knee to be implanted.
2022-09-23
InterSpace Knee ATS Trial Kit - InterSpace Knee ATS Trial Kit is intended to be used for the selection of the right size and thickness of the InterSpace Knee ATS to be implanted.
2022-09-23
InterSpace Knee Trial XL - InterSpace Knee Trial XL is intended to be used for the selection of the right size of InterSpace Knee XL to be implanted.
2022-09-23
Mendec® Kypho Set Monolateral 10 mm - The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intended to provide the end user with either a monolateral or bilateral configuration for use in kyphoplasty procedures.
2025-12-17
Mendec® Kypho Set Monolateral 15 mm - The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intended to provide the end user with either a monolateral or bilateral configuration for use in kyphoplasty procedures.
2025-12-17
Mendec® Kypho Set Monolateral 20 mm - The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intended to provide the end user with either a monolateral or bilateral configuration for use in kyphoplasty procedures.
2025-12-17
Mendec® Kypho Set Bilateral 10 mm - The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intended to provide the end user with either a monolateral or bilateral configuration for use in kyphoplasty procedures.
2025-12-17
Mendec® Kypho Set Bilateral 15 mm - The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intended to provide the end user with either a monolateral or bilateral configuration for use in kyphoplasty procedures.
2025-12-17
Mendec® Kypho Set Bilateral 20 mm - The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intended to provide the end user with either a monolateral or bilateral configuration for use in kyphoplasty procedures.
2025-12-17
Conflow Bone Cement - Conflow Bone Cement is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13,3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. Conflow Bone Cement is indicated for the fixation of joint prosthesis implants to the host bone.
2021-06-09
MectaCem-X LV - MectaCem-X LV is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13,3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X LV is indicated for the fixation of joint prosthesis implants to the host bone.
2021-06-09
MectaCem-X HV - MectaCem-X HV is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13,3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X HV is indicated for the fixation of joint prosthesis implants to the host bone.
2021-06-09
Cemex RX - Cemex RX is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13,3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use.Cemex RX is indicated for the fixation of joint prosthesis implants to the host bone.
2015-10-08
CEMEX ISOPLASTIC - Cemex Isoplastic is a high viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13.3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use.Cemex Isoplastic is indicated for the fixation of joint prosthesis implants to the host bone.
2015-10-08
CEMEX XL - Cemex XL is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (50g powder and 18.33g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use.Cemex XL is indicated for the fixation of joint prosthesis implants to the host bone.
2015-10-08
CEMEX ISOPLASTIC 1/2 PACK - Cemex Isoplastic 1/2 pack is a high viscosity polymethylmethacrylate bone cement. It is composed by two components (20g powder and 6.65g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use.Cemex Isoplastic 1/2 pack is indicated for the fixation of joint prosthesis implants to the host bone.
2015-10-08
2Mix Gun - 2Mix Gun is designed to aid the extrusion of bone cement from 2Mix.
2024-02-12
2Mix - 2Mix is a medical device for mixing bone cement. The device includes several components: mixing container, mixing cap, cannula, pusher-rod and vacuum tube.2Mix is supplied sterile, for single use.
2024-02-12
TEKTONA HV US Bone Cement - TEKTONA HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. TEKTONA HV US Bone Cement is a closed sysyem which containes the powder and liquid components separately. The device is disposable and sterile.
2023-06-08
MENDEC SPINE HV - Mendec Spine HV is a highly viscous radiopaque acrylic resin (PMMA based) indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. The device is disposable and sterile.
2023-06-01
Cement Restrictor - Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device. Cement Restrictor is provided with the related inserter.
2015-10-12
Cement Restrictor - Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device.Cement Restrictor is provided with the related inserter.
2015-10-12
Cement Restrictor - Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device.
2015-10-12
Cement Restrictor - Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device.
2015-10-12
MectaCem BonePrep - 20.00003
2022-11-17
MectaCem Bowl - 20.00004
2022-11-17
BONE INJECTION NEEDLE diamond tip 9 Gauge 150 mm length - BONE INJECTION NEEDLE diamond tip 9 Gauge 150 mm length with plastic handgrip intended for the injection of acrylic resin.
2022-09-23
BONE INJECTION NEEDLE diamond tip 11 Gauge 120 mm length - BONE INJECTION NEEDLE diamond tip 11 Gauge 120 mm length with plastic handgrip intended for the injection of acrylic resin.
2022-09-23