The following data is part of a premarket notification filed by Stuart with the FDA for Sacral Bar.
| Device ID | K843445 |
| 510k Number | K843445 |
| Device Name: | SACRAL BAR |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | STUART ONE STUART PLAZA DONOHUE/LUXOR ROADS Greensburg, PA 15601 |
| Contact | Abraham Glasser |
| Correspondent | Abraham Glasser STUART ONE STUART PLAZA DONOHUE/LUXOR ROADS Greensburg, PA 15601 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-05 |
| Decision Date | 1985-02-13 |