The following data is part of a premarket notification filed by Zavation Medical Products Llc with the FDA for Zavation Buttress Plate System.
Device ID | K180537 |
510k Number | K180537 |
Device Name: | Zavation Buttress Plate System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | Zavation Medical Products LLC 220 Lakeland Parkway Flowood, MS 39232 |
Contact | Matt Jones |
Correspondent | Matt Jones Zavation Medical Products LLC 220 Lakeland Parkway Flowood, MS 39232 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-02-28 |
Decision Date | 2018-03-27 |
Summary: | summary |