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 |