K192394 is an FDA 510(k) clearance for the Hi-Fatigue Bone Cement. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by Osartis GmbH (Dieburg, DE). The FDA issued a Cleared decision on December 2, 2019, 90 days after receiving the submission on September 3, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K192394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2019 |
| Decision Date | December 02, 2019 |
| Days to Decision | 90 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 |