The following data is part of a premarket notification filed by Alliance Partners, Llc with the FDA for Medina Anterior Cervical Plate System.
Device ID | K201521 |
510k Number | K201521 |
Device Name: | Medina Anterior Cervical Plate System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | Alliance Partners, LLC 14206 Northbrook Drive San Antonio, TX 78232 |
Contact | Desiree Crawford |
Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive 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 | 2020-06-08 |
Decision Date | 2020-08-06 |