Tecres SpA
VERONA Veneto, IT
TECRES SPA appears in FDA device records in VERONA Veneto, IT. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Tecres SpA between 2004 and 2025. The busiest year on record is 2006, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2011 | 2 |
| 2013 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252326 | InterSpace GV Hip Spacer | KWL | Substantially Equivalent | |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LV | LOD | Substantially Equivalent | |
| K220131 | KYPHON VuE Bone Cement | NDN | Substantially Equivalent | |
| K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATS | JWH | Substantially Equivalent | |
| K122175 | MENDEC SPINE HV, MENDEC SPINE HV SYSTEM | NDN | Substantially Equivalent | |
| K112983 | SPACER-S | HSD | Substantially Equivalent | |
| K101356 | Spacer-G and Spacer-K | KWL | Substantially Equivalent | |
| K092773 | CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST | LOD | Substantially Equivalent | |
| K062274 | SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 | JWH | Substantially Equivalent | |
| K062273 | SPACER-G TEMPORARY HIP PROSTHESIS | KWL | Substantially Equivalent | |
| K063438 | VSPSPN | NDN | Substantially Equivalent | |
| K062452 | KIT MENDEC SPINE AND DELIVERY SYSTEM | NDN | Substantially Equivalent | |
| K060535 | SPACER-S TEMPORARY SHOULDER SPACER | HSD | Substantially Equivalent | |
| K042415 | MENDEC SPINE | NDN | Substantially Equivalent | |
| K042414 | VISIOPLAST ACRYLIC RESIN | GXP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9614841 | 3002808402 | TECRES SPA | VIA ANDREA DORIA 6, VERONA Veneto 37066 IT | 2026 | and 13 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HRXArthroscope
- LODBone Cement
- MBBBone Cement, Antibiotic
- PMLBone Cement, Posterior Screw Augmentation
- NDNCement, Bone, Vertebroplasty
- KIHDispenser, Cement
- HXKHolder, Needle; Orthopedic
- OARInjector, Vertebroplasty (Does Not Contain Cement)
- KDDKit, Surgical Instrument, Disposable
- GXPMethyl Methacrylate For Cranioplasty
- JDZMixer, Cement, For Clinical Use
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- JDCProsthesis, Elbow, Constrained, Cemented
- JDKProsthesis, Hip, Cement Restrictor
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- OCJSpinal Channeling Instrument, Vertebroplasty
- HXGTamp
- HWTTemplate
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain