The following data is part of a premarket notification filed by Astura Medical with the FDA for Bridalveil Occipital Cervical Thoracic System.
| Device ID | K171250 |
| 510k Number | K171250 |
| Device Name: | BRIDALVEIL Occipital Cervical Thoracic System |
| Classification | Posterior Cervical Screw System |
| Applicant | Astura Medical 3186 Lionshead Ave, Suite 100 Carlsbad, CA 92010 |
| Contact | Troy Taylor |
| Correspondent | Thomas Purcell Astura Medical 3186 Lionshead Ave, Suite 100 Carlsbad, CA 92010 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-28 |
| Decision Date | 2017-10-02 |
| Summary: | summary |