OSF — Patient Specific Manual Orthopedic Stereotaxic System Class II
Classification Details
- Product Code
- OSF
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Neurology
- Implant
- No
Definition
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233315 | surgical planning associates | HipXpert and HipInsight System | August 8, 2024 |
| K200384 | surgical planning associates | HipXpert 3D Display and Anchoring Application | January 28, 2021 |
| K093491 | surgical planning associates | HIP SEXTANT INSTRUMENT SYSTEM | December 9, 2010 |