The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Modification To Pyrenees Cervical Plate System.
| Device ID | K063544 |
| 510k Number | K063544 |
| Device Name: | MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Rich Woods |
| Correspondent | Rich Woods K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-24 |
| Decision Date | 2007-02-14 |
| Summary: | summary |