Cleared Special

SpaceFlex Knee - 80mm Size

K201960 · G21, S.R.L. · Orthopedic
Aug 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K201960 is an FDA 510(k) clearance for the SpaceFlex Knee - 80mm Size, 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 August 13, 2020, 30 days after receiving the submission on July 14, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K201960 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2020
Decision Date August 13, 2020
Days to Decision 30 days
Submission Type Special
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