Cleared Traditional

SpaceFlex Shoulder

K202338 · G21, S.R.L. · Orthopedic
Feb 2021
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K202338 is an FDA 510(k) clearance for the SpaceFlex Shoulder, 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 February 17, 2021, 184 days after receiving the submission on August 17, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K202338 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2020
Decision Date February 17, 2021
Days to Decision 184 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