OSF
- Product code
- OSF
- Device name
- Patient Specific Manual Orthopedic Stereotaxic System
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4560
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
FDA classification definition
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K233315 | 2024-08-08 | Surgical Planning Associates, Inc. | HipXpert and HipInsight System summary |
Official FDA classification page: OSF
Classification and pathway per current FDA publications. Data from openFDA (CC0).