The following data is part of a premarket notification filed by Isotis Nv with the FDA for Shuttle Stop.
| Device ID | K000587 |
| 510k Number | K000587 |
| Device Name: | SHUTTLE STOP |
| Classification | Cement Obturator |
| Applicant | ISOTIS NV 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte ISOTIS NV 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-22 |
| Decision Date | 2000-05-04 |