NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM

Orthopedic Stereotaxic Instrument

NUVASIVE, INC.

The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Bendini Spinal Rod Bending System.

Pre-market Notification Details

Device IDK122742
510k NumberK122742
Device Name:NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
ClassificationOrthopedic Stereotaxic Instrument
Applicant NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
ContactSheila Bruschi
CorrespondentSheila Bruschi
NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-07
Decision Date2012-12-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887517172532 K122742 000
00887517094698 K122742 000

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