The following data is part of a premarket notification filed by Surgicraft Ltd. with the FDA for The Bone Tie.
| Device ID | K982719 |
| 510k Number | K982719 |
| Device Name: | THE BONE TIE |
| Classification | Pin, Fixation, Smooth |
| Applicant | SURGICRAFT LTD. FISHING LINE RD. Redditch, Worcs., GB B97 6hf |
| Contact | Simon Fitzer |
| Correspondent | Simon Fitzer SURGICRAFT LTD. FISHING LINE RD. Redditch, Worcs., GB B97 6hf |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-04 |
| Decision Date | 1998-09-25 |
| Summary: | summary |