The following data is part of a premarket notification filed by K2m, Inc with the FDA for Pyrenees Cervical Plate System.
| Device ID | K142212 |
| 510k Number | K142212 |
| Device Name: | Pyrenees Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M, Inc 751 Miller Drive Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, Inc 751 Miller Drive 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 | 2014-08-12 |
| Decision Date | 2015-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857432413 | K142212 | 000 |
| 10888857030527 | K142212 | 000 |
| 10888857030473 | K142212 | 000 |
| 10888857030084 | K142212 | 000 |
| 10888857030077 | K142212 | 000 |
| 10888857030060 | K142212 | 000 |
| 10888857029965 | K142212 | 000 |
| 10888857029897 | K142212 | 000 |
| 10888857029880 | K142212 | 000 |
| 10888857029866 | K142212 | 000 |
| 10888857029811 | K142212 | 000 |
| 10888857029774 | K142212 | 000 |
| 10888857027077 | K142212 | 000 |
| 10888857479869 | K142212 | 000 |
| 10888857030626 | K142212 | 000 |
| 10888857031135 | K142212 | 000 |
| 10888857427525 | K142212 | 000 |
| 10888857412408 | K142212 | 000 |
| 10888857412392 | K142212 | 000 |
| 10888857381735 | K142212 | 000 |
| 10888857320727 | K142212 | 000 |
| 10888857295032 | K142212 | 000 |
| 10888857260559 | K142212 | 000 |
| 10888857260368 | K142212 | 000 |
| 10888857250482 | K142212 | 000 |
| 10888857249325 | K142212 | 000 |
| 10888857031357 | K142212 | 000 |
| 10888857031340 | K142212 | 000 |
| 10888857031142 | K142212 | 000 |
| 10888857289710 | K142212 | 000 |