Life Spine Cannulated Screws

Screw, Fixation, Bone

LIFE SPINE INC.

The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Life Spine Cannulated Screws.

Pre-market Notification Details

Device IDK150126
510k NumberK150126
Device Name:Life Spine Cannulated Screws
ClassificationScrew, Fixation, Bone
Applicant LIFE SPINE INC. 13951 S. Quality Drive Huntley,  IL  60142
ContactRandy Lewis
CorrespondentRandy Lewis
LIFE SPINE INC. 13951 S. Quality Drive Huntley,  IL  60142
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-20
Decision Date2015-05-11
Summary:summary

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