OSF
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Patient Specific Manual Orthopedic Stereotaxic System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Medical specialty
- Neurology
- FDA definition
- Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
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| Record | Firm | Date |
|---|---|---|
| HipXpert and HipInsight System (K233315) | Surgical Planning Associates, Inc. | 2024-08-08 |
| HipXpert 3D Display and Anchoring Application (K200384) | Surgical Planning Associates, Inc. | 2021-01-28 |
| HIP SEXTANT INSTRUMENT SYSTEM (K093491) | Surgical Planning Associates | 2010-12-09 |
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Every clearance here is in the API, with alerts when new ones post.