The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for British Spinal Fusion Set.
| Device ID | K842698 |
| 510k Number | K842698 |
| Device Name: | BRITISH SPINAL FUSION SET |
| Classification | Guide, Surgical, Instrument |
| Applicant | DOWNS SURGICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FZX |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-11 |
| Decision Date | 1984-09-12 |