K202338 is an FDA 510(k) clearance for the SpaceFlex Shoulder. This device is classified as 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 FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K202338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | MBB - Bone Cement, Antibiotic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |