OSF · Patient Specific Manual Orthopedic Stereotaxic System
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | OSF |
|---|---|
| Device Name | Patient Specific Manual Orthopedic Stereotaxic System |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Classification Rationale
Class II (performance standards).
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233315 | HipXpert and HipInsight System | Surgical Planning Associates, Inc. | Aug 8, 2024 | SESE |
| K200384 | HipXpert 3D Display and Anchoring Application | Surgical Planning Associates, Inc. | Jan 28, 2021 | SESE |
| K093491 | HIP SEXTANT INSTRUMENT SYSTEM | Surgical Planning Associates | Dec 9, 2010 | SESE |
Top Applicants
- Surgical Planning Associates, Inc. — 2 clearances
- Surgical Planning Associates — 1 clearance
