DEN210013 is an FDA 510(k) submission for the OsteoProbe. This device is classified as a Bone Indentation Device (Class II - Special Controls, product code QGQ).
Submitted by Active Life Scientific, Inc. (Santa Barbara, US). The FDA issued a Not Cleared (DENG) decision on August 19, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.1600. A Bone Indentation Device Is A Device That Measures Resistance To Indentation In Bone..
| 510(k) Number | DEN210013 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 30, 2021 |
| Decision Date | August 19, 2021 |
| Days to Decision | 142 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | QGQ - Bone Indentation Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.1600 |
| Definition | A Bone Indentation Device Is A Device That Measures Resistance To Indentation In Bone. |