The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Pyrenees Cervical Plate System.
| Device ID | K152015 |
| 510k Number | K152015 |
| Device Name: | Pyrenees Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M, INC. 751 MILLER DRIVE SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, INC. 751 MILLER DRIVE SE Leesburg, VA 20175 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-21 |
| Decision Date | 2015-09-04 |
| Summary: | summary |