The following data is part of a premarket notification filed by Stuart with the FDA for Anterior Distraction System.
| Device ID | K820034 |
| 510k Number | K820034 |
| Device Name: | ANTERIOR DISTRACTION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | STUART 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-04 |
| Decision Date | 1982-03-11 |