The following data is part of a premarket notification filed by Zavation, Llc with the FDA for Zavation Z-link Lumbar.
Device ID | K142271 |
510k Number | K142271 |
Device Name: | Zavation Z-Link Lumbar |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Applicant | Zavation, LLC 400 Liberty Park Flowood, MS 39232 |
Contact | Lawrence Walker |
Correspondent | Lawrence Walker Zavation, LLC 400 Liberty Park Flowood, MS 39232 |
Product Code | OVD |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-15 |
Decision Date | 2014-12-19 |
Summary: | summary |