The following data is part of a premarket notification filed by Curiteva, Llc with the FDA for Curiteva Anterior Cervical Plate System.
| Device ID | K181562 |
| 510k Number | K181562 |
| Device Name: | Curiteva Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Curiteva, LLC 25127 Will McComb Drive, Suite 100 Tanner, AL 35671 |
| Contact | Eric Linder |
| Correspondent | Eric Linder Curiteva, LLC 25127 Will McComb Drive, Suite 100 Tanner, AL 35671 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-14 |
| Decision Date | 2018-08-02 |