The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Prolift Lateral Fixated.
Device ID | K200338 |
510k Number | K200338 |
Device Name: | ProLift Lateral Fixated |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Applicant | Life Spine Inc. 13951 S Quality Drive Huntley, IL 60142 |
Contact | Angela Batker |
Correspondent | Angela Batker Life Spine Inc. 13951 S Quality Drive Huntley, IL 60142 |
Product Code | OVD |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-02-11 |
Decision Date | 2020-04-17 |