Cleared Traditional

V-STEADY, V-FAST

K150408 · G21, S.R.L. · Orthopedic
Dec 2015
Decision
299d
Days
Class 2
Risk

About This 510(k) Submission

K150408 is an FDA 510(k) clearance for the V-STEADY, V-FAST, a Bone Cement (Class II — Special Controls, product code LOD), submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on December 14, 2015, 299 days after receiving the submission on February 18, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K150408 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2015
Decision Date December 14, 2015
Days to Decision 299 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LOD — Bone Cement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027

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