The following data is part of a premarket notification filed by K2m with the FDA for Pyrenees Cervical Plate System.
| Device ID | K152281 |
| 510k Number | K152281 |
| Device Name: | Pyrenees Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M 751 Miller Drive SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M 751 Miller Drive 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 | 2015-08-12 |
| Decision Date | 2015-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857240988 | K152281 | 000 |
| 10888857240834 | K152281 | 000 |
| 10888857240827 | K152281 | 000 |
| 10888857240810 | K152281 | 000 |
| 10888857240803 | K152281 | 000 |
| 10888857240797 | K152281 | 000 |
| 10888857240780 | K152281 | 000 |
| 10888857240773 | K152281 | 000 |
| 10888857240766 | K152281 | 000 |
| 10888857240759 | K152281 | 000 |
| 10888857240742 | K152281 | 000 |
| 10888857240735 | K152281 | 000 |
| 10888857240728 | K152281 | 000 |
| 10888857240841 | K152281 | 000 |
| 10888857240858 | K152281 | 000 |
| 10888857240971 | K152281 | 000 |
| 10888857240964 | K152281 | 000 |
| 10888857240957 | K152281 | 000 |
| 10888857240940 | K152281 | 000 |
| 10888857240933 | K152281 | 000 |
| 10888857240926 | K152281 | 000 |
| 10888857240919 | K152281 | 000 |
| 10888857240902 | K152281 | 000 |
| 10888857240896 | K152281 | 000 |
| 10888857240889 | K152281 | 000 |
| 10888857240872 | K152281 | 000 |
| 10888857240865 | K152281 | 000 |
| 10888857240711 | K152281 | 000 |