The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Transom Anterior Cervical Plate.
Device ID | K142060 |
510k Number | K142060 |
Device Name: | TRANSOM ANTERIOR CERVICAL PLATE |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | NEUROSTRUCTURES, INC. 4628 NORTHPARK DR. Colorado Springs, CO 80918 |
Contact | Meredith May |
Correspondent | Meredith May NEUROSTRUCTURES, INC. 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 | 2014-07-29 |
Decision Date | 2014-11-18 |
Summary: | summary |