NuVasive Reline Cervical System

Posterior Cervical Screw System

NuVasive, Incorporated

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Reline Cervical System.

Pre-market Notification Details

Device IDK221388
510k NumberK221388
Device Name:NuVasive Reline Cervical System
ClassificationPosterior Cervical Screw System
Applicant NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
ContactSali Gully
CorrespondentSali Gully
NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-13
Decision Date2022-09-09

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