INCITE ANCHORED CERVICAL INTERBODY DEVICE

Intervertebral Fusion Device With Integrated Fixation, Cervical

INCITE INNOVATION

The following data is part of a premarket notification filed by Incite Innovation with the FDA for Incite Anchored Cervical Interbody Device.

Pre-market Notification Details

Device IDK150913
510k NumberK150913
Device Name:INCITE ANCHORED CERVICAL INTERBODY DEVICE
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant INCITE INNOVATION 1500 MAIN STREET, SUITE 2410 Springfield,  MA  01115 -5707
ContactJohn Kirwan
CorrespondentRenee Murphy
ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad,  CA  92008
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-06
Decision Date2015-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840967123486 K150913 000
00840180503492 K150913 000
00840180503508 K150913 000
00840180503515 K150913 000
00840180503522 K150913 000
00840180503539 K150913 000
00840180503546 K150913 000
00840180503553 K150913 000
00840180503560 K150913 000
00840180503577 K150913 000
00840180503584 K150913 000
00840180503591 K150913 000
00811801032554 K150913 000

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