K193059 is an FDA 510(k) clearance for the G1 40 Radiopaque Bone Cement. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on March 19, 2020, 139 days after receiving the submission on November 1, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K193059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2019 |
| Decision Date | March 19, 2020 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LOD - Bone Cement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |