MIS ANTERIOR CERVICAL PLATING 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 Mis Anterior Cervical Plating System.

Pre-market Notification Details

Device IDK103423
510k NumberK103423
Device Name:MIS ANTERIOR CERVICAL PLATING SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates,  IL  60169
ContactRandy Lewis
CorrespondentRandy Lewis
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 Received2010-11-22
Decision Date2011-06-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190837044817 K103423 000
00190837044985 K103423 000
00190837044992 K103423 000
00190837045005 K103423 000
00190837045012 K103423 000
00190837045029 K103423 000
00190837045036 K103423 000
00190837045043 K103423 000
00190837045050 K103423 000
00190837045067 K103423 000
00190837045074 K103423 000
00190837044893 K103423 000
00190837008390 K103423 000
00190837044978 K103423 000
00190837044961 K103423 000
00190837044954 K103423 000
00190837044824 K103423 000
00190837044831 K103423 000
00190837044848 K103423 000
00190837044855 K103423 000
00190837044862 K103423 000
00190837044879 K103423 000
00190837044886 K103423 000
00190837044909 K103423 000
00190837044916 K103423 000
00190837044923 K103423 000
00190837044930 K103423 000
00190837044947 K103423 000
00190837008406 K103423 000
00190837008413 K103423 000
00190837008574 K103423 000
00190837008581 K103423 000
00190837008598 K103423 000
00190837008604 K103423 000
00190837008611 K103423 000
00190837008628 K103423 000
00190837008635 K103423 000
00190837008642 K103423 000
00190837008659 K103423 000
00190837008666 K103423 000
00190837008673 K103423 000
00190837008680 K103423 000
00190837008567 K103423 000
00190837008550 K103423 000
00190837008543 K103423 000
00190837008420 K103423 000
00190837008437 K103423 000
00190837008444 K103423 000
00190837008451 K103423 000
00190837008468 K103423 000
00190837008475 K103423 000
00190837008482 K103423 000
00190837008499 K103423 000
00190837008505 K103423 000
00190837008512 K103423 000
00190837008529 K103423 000
00190837008536 K103423 000
00190837008697 K103423 000

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