The following data is part of a premarket notification filed by Advanced Osseous Technologies with the FDA for System Ten, Model 100 Surgery Syst/orthopaedic Use.
| Device ID | K905451 |
| 510k Number | K905451 |
| Device Name: | SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | ADVANCED OSSEOUS TECHNOLOGIES C/O CHARLES L. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose ADVANCED OSSEOUS TECHNOLOGIES C/O CHARLES L. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-05 |
| Decision Date | 1991-03-05 |