The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Cannulated Lag Screws.
| Device ID | K863119 |
| 510k Number | K863119 |
| Device Name: | CANNULATED LAG SCREWS |
| Classification | Pin, Fixation, Smooth |
| Applicant | DOWNS SURGICAL LTD. PARKWAY CLOSE,PARKWAY INDUSTRIAL ESTATE Sheffield S9 4wj, GB |
| Contact | Geoffrey Down |
| Correspondent | Geoffrey Down DOWNS SURGICAL LTD. PARKWAY CLOSE,PARKWAY INDUSTRIAL ESTATE Sheffield S9 4wj, GB |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-14 |
| Decision Date | 1986-09-03 |