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 |