ProLift Lateral Fixated

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Life Spine Inc.

The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Prolift Lateral Fixated.

Pre-market Notification Details

Device IDK200338
510k NumberK200338
Device Name:ProLift Lateral Fixated
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Life Spine Inc. 13951 S Quality Drive Huntley,  IL  60142
ContactAngela Batker
CorrespondentAngela Batker
Life Spine Inc. 13951 S Quality Drive Huntley,  IL  60142
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-11
Decision Date2020-04-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190837101428 K200338 000
00190837101268 K200338 000
00190837101275 K200338 000
00190837101282 K200338 000
00190837101299 K200338 000
00190837101305 K200338 000
00190837101312 K200338 000
00190837101329 K200338 000
00190837101336 K200338 000
00190837101343 K200338 000
00190837101350 K200338 000
00190837101251 K200338 000
00190837101237 K200338 000
00190837101435 K200338 000
00190837101442 K200338 000
00190837101459 K200338 000
00190837101466 K200338 000
00190837101473 K200338 000
00190837101480 K200338 000
00190837101497 K200338 000
00190837101503 K200338 000
00190837101510 K200338 000
00190837101220 K200338 000
00190837101367 K200338 000
00190837101374 K200338 000
00190837101176 K200338 000
00190837101183 K200338 000
00190837101206 K200338 000
00190837101213 K200338 000
00190837101060 K200338 000
00190837101244 K200338 000
00190837101190 K200338 000
00190837101138 K200338 000
00190837101107 K200338 000
00190837101114 K200338 000
00190837101169 K200338 000
00190837101152 K200338 000
00190837101381 K200338 000
00190837101398 K200338 000
00190837101404 K200338 000
00190837101411 K200338 000
00190837101046 K200338 000
00190837101053 K200338 000
00190837101077 K200338 000
00190837101084 K200338 000
00190837101091 K200338 000
00190837101145 K200338 000
00190837101121 K200338 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.