Cleared Traditional

MENDEC SPINE

K042415 · Tecres S.P.A. · Orthopedic
Jun 2005
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K042415 is an FDA 510(k) clearance for the MENDEC SPINE, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Tecres S.P.A. (Bethesda, US). The FDA issued a Cleared decision on June 9, 2005, 275 days after receiving the submission on September 7, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K042415 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2004
Decision Date June 09, 2005
Days to Decision 275 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code NDN — Cement, Bone, Vertebroplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027

Similar Devices — NDN Cement, Bone, Vertebroplasty

All 107
XeliteMed SuperM-Fix Spinal Bone Cement
K251896 · Xelite Biomed , Ltd. · Jan 2026
VCFix Spinal System
K250637 · Amber Implants · May 2025
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
K243537 · Xelite Biomed , Ltd. · Apr 2025
XeliteMed VertehighFix High Viscosity Spinal Bone Cement
K241775 · Xelite Biomed , Ltd. · Sep 2024
Balloon Inflation System
K232842 · Ningbo Hicren Biotechnology Co., Ltd. · Feb 2024
V-STRUT? Vertebral Implant
K240084 · Hyprevention · Feb 2024