Cleared Traditional

G21 SpaceFlex Hip

K192041 · G21, S.R.L. · Orthopedic
Oct 2019
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K192041 is an FDA 510(k) clearance for the G21 SpaceFlex Hip, a Bone Cement, Antibiotic (Class II — Special Controls, product code MBB), submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on October 29, 2019, 90 days after receiving the submission on July 31, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K192041 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2019
Decision Date October 29, 2019
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBB — Bone Cement, Antibiotic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027