NFIX FUSION SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

N-SPINE, INC.

The following data is part of a premarket notification filed by N-spine, Inc. with the FDA for Nfix Fusion System.

Pre-market Notification Details

Device IDK053623
510k NumberK053623
Device Name:NFIX FUSION SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant N-SPINE, INC. P.O. BOX 560 Stillwater,  MN  55082
ContactElaine Duncan
CorrespondentElaine Duncan
N-SPINE, INC. P.O. BOX 560 Stillwater,  MN  55082
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-28
Decision Date2006-07-12
Summary:summary

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