K221195 is an FDA 510(k) clearance 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 Cleared decision on June 28, 2022, 64 days after receiving the submission on April 25, 2022.
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 | K221195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2022 |
| Decision Date | June 28, 2022 |
| Days to Decision | 64 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| 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. |