The following data is part of a premarket notification filed by K2m, Llc with the FDA for Tectonic Cervical Plate System.
| Device ID | K051531 |
| 510k Number | K051531 |
| Device Name: | TECTONIC CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M, LLC 751 MILLER DR.,S.E., SUITE F1 Leesburg, VA 20175 |
| Contact | Rich Woods |
| Correspondent | Rich Woods K2M, LLC 751 MILLER DR.,S.E., SUITE F1 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 | 2005-06-09 |
| Decision Date | 2005-10-17 |
| Summary: | summary |