K250216 is an FDA 510(k) clearance for the OsteoProbe (OP-100). 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 September 11, 2025, 230 days after receiving the submission on January 24, 2025.
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 | K250216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2025 |
| Decision Date | September 11, 2025 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| 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. |