2-Piece Hammertoe Correction System

Screw, Fixation, Bone

Life Spine, Inc.

The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for 2-piece Hammertoe Correction System.

Pre-market Notification Details

Device IDK162685
510k NumberK162685
Device Name:2-Piece Hammertoe Correction System
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 Received2016-09-26
Decision Date2017-06-09
Summary:summary

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