Company ยท US
Tecres S.P.A.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2025. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 6, 2025 | K252326 | InterSpace GV Hip Spacer Tecres S.P.A., IT | KWL |
| Jan 9, 2023 | K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LV Tecres S.P.A., IT | LOD |
| Apr 18, 2022 | K220131 | KYPHON VuE Bone Cement Tecres S.P.A., IT | NDN |
| Apr 27, 2019 | K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATS Tecres S.P.A., IT | JWH |
| Mar 28, 2013 | K122175 | MENDEC SPINE HV, MENDEC SPINE HV SYSTEM Tecres S.P.A. | NDN |
| Dec 12, 2011 | K112983 | SPACER-S Tecres S.P.A. | HSD |
| Sep 20, 2011 | K101356 | Spacer-G and Spacer-K Tecres S.P.A. | KWL |
| Nov 24, 2009 | K092773 | CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST Tecres S.P.A. | LOD |
| May 22, 2008 | K062274 | SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 Tecres S.P.A. | JWH |
| May 22, 2008 | K062273 | SPACER-G TEMPORARY HIP PROSTHESIS Tecres S.P.A. | KWL |
| Jan 17, 2007 | K063438 | VSPSPN Tecres S.P.A. | NDN |
| Sep 21, 2006 | K062452 | KIT MENDEC SPINE AND DELIVERY SYSTEM Tecres S.P.A. | NDN |
| May 24, 2006 | K060535 | SPACER-S TEMPORARY SHOULDER SPACER Tecres S.P.A. | HSD |
| Jun 9, 2005 | K042415 | MENDEC SPINE Tecres S.P.A. | NDN |
| Dec 29, 2004 | K042414 | VISIOPLAST ACRYLIC RESIN Tecres | GXP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||