Tecres S.P.A.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
3
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K252326InterSpace GV Hip SpacerAugust 6, 2025
K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVJanuary 9, 2023
K220131KYPHON VuE Bone CementApril 18, 2022
K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSApril 27, 2019
K122175MENDEC SPINE HV, MENDEC SPINE HV SYSTEMMarch 28, 2013
K112983SPACER-SDecember 12, 2011
K101356Spacer-G and Spacer-KSeptember 20, 2011
K092773CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FASTNovember 24, 2009
K062274SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321May 22, 2008
K062273SPACER-G TEMPORARY HIP PROSTHESISMay 22, 2008
K063438VSPSPNJanuary 17, 2007
K062452KIT MENDEC SPINE AND DELIVERY SYSTEMSeptember 21, 2006
K060535SPACER-S TEMPORARY SHOULDER SPACERMay 24, 2006
K042415MENDEC SPINEJune 9, 2005
K042414VISIOPLAST ACRYLIC RESINDecember 29, 2004