Simplify Disc

Manual Instruments Designed For Use With Total Disc Replacement Devices

NuVasive, Inc.

The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Simplify Disc.

Pre-market Notification Details

Device IDK211757
510k NumberK211757
Device Name:Simplify Disc
ClassificationManual Instruments Designed For Use With Total Disc Replacement Devices
Applicant NuVasive, Inc. 685 North Pastoria Avenue Sunnyvale,  CA  94085
ContactBeth Neil
CorrespondentJustin Eggleton
MCRA, LLC 1050 K Street NW, Suite 1000 Washington,  DC  20001
Product CodeQLQ  
CFR Regulation Number888.4515 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-07
Decision Date2021-08-20

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