The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Pyrenees Cervical Plate System (translational Plates).
| Device ID | K111135 |
| 510k Number | K111135 |
| Device Name: | PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen 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 | 2011-04-22 |
| Decision Date | 2011-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857028777 | K111135 | 000 |
| 10888857029002 | K111135 | 000 |
| 10888857029019 | K111135 | 000 |
| 10888857029026 | K111135 | 000 |
| 10888857029033 | K111135 | 000 |
| 10888857029040 | K111135 | 000 |
| 10888857029057 | K111135 | 000 |
| 10888857029064 | K111135 | 000 |
| 10888857029071 | K111135 | 000 |
| 10888857028999 | K111135 | 000 |
| 10888857028982 | K111135 | 000 |
| 10888857028791 | K111135 | 000 |
| 10888857028807 | K111135 | 000 |
| 10888857028814 | K111135 | 000 |
| 10888857028821 | K111135 | 000 |
| 10888857028838 | K111135 | 000 |
| 10888857028845 | K111135 | 000 |
| 10888857028852 | K111135 | 000 |
| 10888857028869 | K111135 | 000 |
| 10888857029088 | K111135 | 000 |
| 10888857029293 | K111135 | 000 |
| 10888857029309 | K111135 | 000 |
| 10888857029507 | K111135 | 000 |
| 10888857029514 | K111135 | 000 |
| 10888857029521 | K111135 | 000 |
| 10888857029538 | K111135 | 000 |
| 10888857029545 | K111135 | 000 |
| 10888857029552 | K111135 | 000 |
| 10888857029569 | K111135 | 000 |
| 10888857029576 | K111135 | 000 |
| 10888857029491 | K111135 | 000 |
| 10888857029392 | K111135 | 000 |
| 10888857029316 | K111135 | 000 |
| 10888857029323 | K111135 | 000 |
| 10888857029330 | K111135 | 000 |
| 10888857029347 | K111135 | 000 |
| 10888857029354 | K111135 | 000 |
| 10888857029361 | K111135 | 000 |
| 10888857029378 | K111135 | 000 |
| 10888857029385 | K111135 | 000 |
| 10888857029583 | K111135 | 000 |