The following data is part of a premarket notification filed by Neurostructures, Llc with the FDA for Tempus Cervical Plate System.
| Device ID | K120515 |
| 510k Number | K120515 |
| Device Name: | TEMPUS CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | NEUROSTRUCTURES, LLC 4628 NORTHPARK DR Colorado Springs, CO 80918 |
| Contact | Meredith May |
| Correspondent | Meredith May NEUROSTRUCTURES, LLC 4628 NORTHPARK DR Colorado Springs, CO 80918 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-05-23 |
| Summary: | summary |