The following data is part of a premarket notification filed by Eisertech, Llc with the FDA for Cervical Plate.
Device ID | K190565 |
510k Number | K190565 |
Device Name: | Cervical Plate |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | EiserTech, LLC 9988 Hibert Street Suite 302 San Diego, CA 92131 |
Contact | Lukas Eisermann |
Correspondent | Dawn Norman MRC-X, LLC 6075 Poplar Ave Memphis, TN 38119 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-05 |
Decision Date | 2019-05-31 |