TruLift Expandable Spacer System

Intervertebral Fusion Device With Bone Graft, Lumbar

Life Spine Inc.

The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Trulift Expandable Spacer System.

Pre-market Notification Details

Device IDK201721
510k NumberK201721
Device Name:TruLift Expandable Spacer System
ClassificationIntervertebral Fusion Device With Bone Graft, 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 CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-23
Decision Date2020-09-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190837097196 K201721 000
00190837097400 K201721 000
00190837097417 K201721 000
00190837097424 K201721 000
00190837097431 K201721 000
00190837097448 K201721 000
00190837097455 K201721 000
00190837097462 K201721 000
00190837097479 K201721 000
00190837097486 K201721 000
00190837097493 K201721 000
00190837097394 K201721 000
00190837097387 K201721 000
00190837097202 K201721 000
00190837097219 K201721 000
00190837097226 K201721 000
00190837097233 K201721 000
00190837097240 K201721 000
00190837097257 K201721 000
00190837097264 K201721 000
00190837097356 K201721 000
00190837097363 K201721 000
00190837097370 K201721 000
00190837097509 K201721 000
00190837097516 K201721 000
00190837097646 K201721 000
00190837097653 K201721 000
00190837097660 K201721 000
00190837097301 K201721 000
00190837097325 K201721 000
00190837097295 K201721 000
00190837097332 K201721 000
00190837097349 K201721 000
00190837097318 K201721 000
00190837097288 K201721 000
00190837097639 K201721 000
00190837097622 K201721 000
00190837097523 K201721 000
00190837097530 K201721 000
00190837097547 K201721 000
00190837097554 K201721 000
00190837097561 K201721 000
00190837097578 K201721 000
00190837097585 K201721 000
00190837097592 K201721 000
00190837097608 K201721 000
00190837097615 K201721 000
00190837097271 K201721 000

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.