K153737 is an FDA 510(k) clearance for the OSTEOPAL plus. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on April 22, 2016, 116 days after receiving the submission on December 28, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K153737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2015 |
| Decision Date | April 22, 2016 |
| Days to Decision | 116 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LOD - Bone Cement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |