The following data is part of a premarket notification filed by Corelink Llc with the FDA for Anodyne Anterior Cervical Plate System.
| Device ID | K121514 |
| 510k Number | K121514 |
| Device Name: | ANODYNE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | CORELINK LLC 1331 H STREET 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton CORELINK LLC 1331 H STREET 12TH FLOOR Washington, DC 20005 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-22 |
| Decision Date | 2012-12-14 |
| Summary: | summary |