Patient Specific Manual Orthopedic Stereotaxic System
Regulation 882.4560
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OSF
| Company | 510(k)s | Recalls |
|---|---|---|
| Surgical Planning Associates | 3 | 0 |
| Materialise N.V. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 8, 2024 | K233315 | HipXpert and HipInsight System Surgical Planning Associates, Inc. | OSF |
| Jan 28, 2021 | K200384 | HipXpert 3D Display and Anchoring Application Surgical Planning Associates, Inc. | OSF |
| Dec 9, 2010 | K093491 | HIP SEXTANT INSTRUMENT SYSTEM Surgical Planning Associates | OSF |
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