ROSA® Shoulder System
Device Facts
| Record ID | K260582 |
|---|---|
| Device Name | ROSA® Shoulder System |
| Applicant | Orthosoft Inc. (d/b/a) Zimmer CAS |
| Product Code | OLO · Neurology |
| Decision Date | May 21, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
Regulatory Classification
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.
