Medical Device Manufacturer · US , Bethesda , MD

Tecres S.P.A.

14 submissions · 14 cleared · Since 2005
14
Total
14
Cleared
0
Denied

Tecres S.P.A. — FDA 510(k) Submissions

Tecres S.P.A. has submitted 14 FDA 510(k) premarket notifications since 2005, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Cement, Bone, Vertebroplasty, Prosthesis, Hip, Hemi-, Femoral, Metal, Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Bone Cement . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
InterSpace GV Hip Spacer
K252326 · KWL Prosthesis, Hip, Hemi-,... · Orthopedic
Aug 2025 12d
Bone Cement Genta, Bone Cement HV, Bone Cement LV
K211163 · LOD Bone Cement · Orthopedic
Jan 2023 630d
KYPHON VuE Bone Cement
K220131 · NDN Cement, Bone, Vertebroplasty · Orthopedic
Apr 2022 90d
InterSpace Knee Extra-Large Size, InterSpace Knee ATS
K181732 · JWH Prosthesis, Knee,... · Orthopedic
Apr 2019 299d
MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
K122175 · NDN Cement, Bone, Vertebroplasty · Orthopedic
Mar 2013 248d
SPACER-S
K112983 · HSD Prosthesis, Shoulder,... · Orthopedic
Dec 2011 67d
Spacer-G and Spacer-K
K101356 · KWL Prosthesis, Hip, Hemi-,... · Orthopedic
Sep 2011 494d
CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST
K092773 · LOD Bone Cement · Orthopedic
Nov 2009 76d
SPACER-G TEMPORARY HIP PROSTHESIS
K062273 · KWL Prosthesis, Hip, Hemi-,... · Orthopedic
May 2008 654d
SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321
K062274 · JWH Prosthesis, Knee,... · Orthopedic
May 2008 654d
VSPSPN
K063438 · NDN Cement, Bone, Vertebroplasty · Orthopedic
Jan 2007 64d
KIT MENDEC SPINE AND DELIVERY SYSTEM
K062452 · NDN Cement, Bone, Vertebroplasty · Orthopedic
Sep 2006 30d
SPACER-S TEMPORARY SHOULDER SPACER
K060535 · HSD Prosthesis, Shoulder,... · Orthopedic
May 2006 85d
MENDEC SPINE
K042415 · NDN Cement, Bone, Vertebroplasty · Orthopedic
Jun 2005 275d
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