K190216 is an FDA 510(k) clearance for the SpaceFlex Knee. This device is classified as 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 FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K190216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | MBB - Bone Cement, Antibiotic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |