ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS
Device Facts
| Record ID | K941364 |
|---|---|
| Device Name | ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS |
| Applicant | Acufex Microsurgical, Inc. |
| Product Code | HRX · Orthopedic |
| Decision Date | May 16, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
