SYSTEM TEN MODEL 100 SURGICAL SYSTEM
Device Facts
| Record ID | K900003 |
|---|---|
| Device Name | SYSTEM TEN MODEL 100 SURGICAL SYSTEM |
| Applicant | Advanced Osseous Technologies |
| Product Code | JDX · Orthopedic |
| Decision Date | Mar 16, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.4580 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.
