FDA Product Code
FDA Product Code OSF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233315 | HipXpert and HipInsight System | Surgical Planning Associates, Inc. | 2024-08-08 | Traditional | PDF ↗ |
| K200384 | HipXpert 3D Display and Anchoring Application | Surgical Planning Associates, Inc. | 2021-01-28 | Traditional | PDF ↗ |
| K093491 | HIP SEXTANT INSTRUMENT SYSTEM | Surgical Planning Associates | 2010-12-09 | Traditional | PDF ↗ |
Product code OSF · Class II · Neurology. Data: openFDA.