The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Pyrenees Cervical Plate System.
| Device ID | K162664 |
| 510k Number | K162664 |
| Device Name: | Pyrenees Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M, Inc. 600 HOPE PKWY SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, Inc. 600 HOPE PKWY 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 | 2016-09-26 |
| Decision Date | 2016-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857327139 | K162664 | 000 |
| 10888857327030 | K162664 | 000 |
| 10888857327047 | K162664 | 000 |
| 10888857327054 | K162664 | 000 |
| 10888857327061 | K162664 | 000 |
| 10888857327078 | K162664 | 000 |
| 10888857327085 | K162664 | 000 |
| 10888857327092 | K162664 | 000 |
| 10888857327108 | K162664 | 000 |
| 10888857327115 | K162664 | 000 |
| 10888857327122 | K162664 | 000 |
| 10888857327023 | K162664 | 000 |