NGARDE SYSTEM

Posterior Metal/polymer Spinal System, Fusion

N SPINE, INC.

The following data is part of a premarket notification filed by N Spine, Inc. with the FDA for Ngarde System.

Pre-market Notification Details

Device IDK072685
510k NumberK072685
Device Name:NGARDE SYSTEM
ClassificationPosterior Metal/polymer Spinal System, Fusion
Applicant N SPINE, INC. 6244 FERRIS SQUARE, SUITE B San Diego,  CA  92121 -3239
ContactJude V Paganelli
CorrespondentJude V Paganelli
N SPINE, INC. 6244 FERRIS SQUARE, SUITE B San Diego,  CA  92121 -3239
Product CodeNQP  
CFR Regulation Number888.3070 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-21
Decision Date2007-10-19
Summary:summary

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