Cleared Traditional

OrthoSteady G Bone Cement

K173494 · G21, S.R.L. · Orthopedic
Mar 2018
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K173494 is an FDA 510(k) clearance for the OrthoSteady G Bone Cement, 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 March 6, 2018, 113 days after receiving the submission on November 13, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K173494 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2017
Decision Date March 06, 2018
Days to Decision 113 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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