The following data is part of a premarket notification filed by Spine Vision, Inc with the FDA for C3 Anterior Cervical Plate System.
| Device ID | K012881 |
| 510k Number | K012881 |
| Device Name: | C3 ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SPINE VISION, INC BOX 39 367 PLEASANT VALLEY RD. Good Hope, GA 30641 |
| Contact | David W Mullis, Jr |
| Correspondent | David W Mullis, Jr SPINE VISION, INC BOX 39 367 PLEASANT VALLEY RD. Good Hope, GA 30641 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-28 |
| Decision Date | 2001-11-26 |
| Summary: | summary |