LIFE SPINE LUMBAR PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

LIFE SPINE

The following data is part of a premarket notification filed by Life Spine with the FDA for Life Spine Lumbar Plate System.

Pre-market Notification Details

Device IDK093200
510k NumberK093200
Device Name:LIFE SPINE LUMBAR PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates,  IL  60169
ContactCharles Gill
CorrespondentCharles Gill
LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates,  IL  60169
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-09
Decision Date2010-01-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190837013172 K093200 000
00190837043377 K093200 000
00190837043360 K093200 000
00190837043353 K093200 000
00190837043346 K093200 000
00190837043339 K093200 000
00190837043322 K093200 000
00190837043315 K093200 000
00190837043308 K093200 000
00190837043292 K093200 000
00190837043285 K093200 000
00190837043384 K093200 000
00190837043391 K093200 000
00190837043407 K093200 000
00190837013165 K093200 000
00190837013158 K093200 000
00190837013141 K093200 000
00190837013134 K093200 000
00190837013127 K093200 000
00190837013110 K093200 000
00190837013103 K093200 000
00190837043438 K093200 000
00190837043421 K093200 000
00190837043414 K093200 000
00190837043278 K093200 000
00190837043261 K093200 000
00190837043124 K093200 000
00190837043117 K093200 000
00190837043100 K093200 000
00190837043094 K093200 000
00190837043087 K093200 000
00190837043070 K093200 000
00190837043063 K093200 000
00190837043056 K093200 000
00190837043049 K093200 000
00190837043032 K093200 000
00190837043131 K093200 000
00190837043148 K093200 000
00190837043155 K093200 000
00190837043254 K093200 000
00190837043247 K093200 000
00190837043230 K093200 000
00190837043223 K093200 000
00190837043216 K093200 000
00190837043209 K093200 000
00190837043193 K093200 000
00190837043186 K093200 000
00190837043179 K093200 000
00190837043162 K093200 000
00190837043025 K093200 000
00190837016777 K093200 000
00190837016630 K093200 000
00190837016623 K093200 000
00190837016616 K093200 000
00190837016609 K093200 000
00190837016593 K093200 000
00190837016586 K093200 000
00190837016579 K093200 000
00190837013462 K093200 000
00190837013455 K093200 000
00190837013448 K093200 000
00190837016647 K093200 000
00190837016654 K093200 000
00190837016661 K093200 000
00190837016760 K093200 000
00190837016753 K093200 000
00190837016746 K093200 000
00190837016739 K093200 000
00190837016722 K093200 000
00190837016715 K093200 000
00190837016708 K093200 000
00190837016692 K093200 000
00190837016685 K093200 000
00190837016678 K093200 000
00190837013431 K093200 000
00190837013424 K093200 000
00190837013288 K093200 000
00190837013271 K093200 000
00190837013264 K093200 000
00190837013257 K093200 000
00190837013240 K093200 000
00190837013233 K093200 000
00190837013226 K093200 000
00190837013219 K093200 000
00190837013202 K093200 000
00190837013196 K093200 000
00190837013295 K093200 000
00190837013301 K093200 000
00190837013318 K093200 000
00190837013417 K093200 000
00190837013400 K093200 000
00190837013394 K093200 000
00190837013387 K093200 000
00190837013370 K093200 000
00190837013363 K093200 000
00190837013356 K093200 000
00190837013349 K093200 000
00190837013332 K093200 000
00190837013325 K093200 000
00190837013189 K093200 000

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