The following data is part of a premarket notification filed by Corelink Llc with the FDA for Anodyne Anterior Cervical Plate System.
| Device ID | K132994 |
| 510k Number | K132994 |
| Device Name: | ANODYNE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | CORELINK LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb CORELINK LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-24 |
| Decision Date | 2013-12-05 |
| Summary: | summary |