The following data is part of a premarket notification filed by Astura Medical with the FDA for Bridalveil Navigated Instruments.
| Device ID | K182982 |
| 510k Number | K182982 |
| Device Name: | BridalVeil Navigated Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Astura Medical 3186 Lionshead Ave. Suite 100 Carlsbad, CA 92010 |
| Contact | Parker Kelch |
| Correspondent | Parker Kelch Astura Medical 3186 Lionshead Ave. Suite 100 Carlsbad, CA 92010 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-29 |
| Decision Date | 2019-01-04 |
| Summary: | summary |