The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Modified Huckstep Intramedullary Nail.
| Device ID | K871947 |
| 510k Number | K871947 |
| Device Name: | MODIFIED HUCKSTEP INTRAMEDULLARY NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DOWNS SURGICAL LTD. PARKWAY CLOSE,PARKWAY INDUSTRIAL ESTATE Sheffield S9 4wj, GB |
| Contact | Geoffrey W Down |
| Correspondent | Geoffrey W Down DOWNS SURGICAL LTD. PARKWAY CLOSE,PARKWAY INDUSTRIAL ESTATE Sheffield S9 4wj, GB |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-19 |
| Decision Date | 1987-08-05 |