Cleared Traditional

SpaceFlex Knee

K190216 · G21, S.R.L. · Orthopedic
Jun 2019
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K190216 is an FDA 510(k) clearance for the SpaceFlex Knee, a Bone Cement, Antibiotic (Class II — Special Controls, product code MBB), submitted by G21, S.R.L. (San Possidomio, IT). The FDA issued a Cleared decision on June 9, 2019, 125 days after receiving the submission on February 4, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K190216 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2019
Decision Date June 09, 2019
Days to Decision 125 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