OsteoProbe (OP-100)
FDA 510(k) clearance K250216 · decided 2025-09-11
Clearance details
- K-number
- K250216
- Device name
- OsteoProbe (OP-100)
- Applicant
- Active Life Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-24
- Decision date
- 2025-09-11
- Days to decision
- 230 days
- Clearance type
- Traditional
- Product code
- QGQ
- Device class
- 2
- Regulation number
- 888.1600
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Santa Barbara, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OsteoProbe (K221195) | Active Life Scientific, Inc. | 2022-06-28 |
| OsteoProbe (DEN210013) | Active Life Scientific, Inc. | 2021-08-19 |
Recalls involving this device
No recalls on record reference this clearance.