The following data is part of a premarket notification filed by Biomet Spine (aka Ebi, Llc) with the FDA for Maxan Anterior Cervical Plate System.
| Device ID | K133518 |
| 510k Number | K133518 |
| Device Name: | MAXAN ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | BIOMET SPINE (AKA EBI, LLC) 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Kimberly Mccoy |
| Correspondent | Spencer Kimber BIOMET SPINE (AKA EBI, LLC) 399 JEFFERSON ROAD 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 | 2013-11-15 |
| Decision Date | 2014-11-05 |
| Summary: | summary |