CROSSWAY Spinal Access System
Device Facts
| Record ID | K190598 |
|---|---|
| Device Name | CROSSWAY Spinal Access System |
| Applicant | Globus Medical, Inc. |
| Product Code | HRX · Orthopedic |
| Decision Date | Apr 5, 2019 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.1100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
Submission Summary (Full Text)
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