The following data is part of a premarket notification filed by Biomet Spine with the FDA for C-tek Maxan Anterior Cervical Plate System.
| Device ID | K080646 |
| 510k Number | K080646 |
| Device Name: | C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | BIOMET SPINE 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Jacquelyn A Hughes |
| Correspondent | Jacquelyn A Hughes BIOMET SPINE 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-06 |
| Decision Date | 2008-05-02 |
| Summary: | summary |