The following data is part of a premarket notification filed by Zavation, Llc with the FDA for Zavation Ibf.
Device ID | K162206 |
510k Number | K162206 |
Device Name: | Zavation IBF |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Zavation, LLC 220 Lakeland Pkwy Flowood, MS 39232 |
Contact | Lawrence Walker |
Correspondent | Lawrence Walker Zavation, LLC 220 Lakeland Pkwy Flowood, MS 39232 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-08-05 |
Decision Date | 2017-04-04 |
Summary: | summary |