Cleared Traditional

MENDEC SPINE HV, MENDEC SPINE HV SYSTEM

K122175 · Tecres S.P.A. · Orthopedic
Mar 2013
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K122175 is an FDA 510(k) clearance for the MENDEC SPINE HV, MENDEC SPINE HV SYSTEM, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Tecres S.P.A. (Rockville, US). The FDA issued a Cleared decision on March 28, 2013, 248 days after receiving the submission on July 23, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K122175 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2012
Decision Date March 28, 2013
Days to Decision 248 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

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