Integra Laminoplasty System

Orthosis, Spine, Plate, Laminoplasty, Metal

SEASPINE, INC.

The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Integra Laminoplasty System.

Pre-market Notification Details

Device IDK150469
510k NumberK150469
Device Name:Integra Laminoplasty System
ClassificationOrthosis, Spine, Plate, Laminoplasty, Metal
Applicant SEASPINE, INC. 2302 LA MIRADA DRIVE Vista,  CA  92081
ContactMichelle Willis
CorrespondentMichelle Willis
SEASPINE, INC. 2302 LA MIRADA DRIVE Vista,  CA  92081
Product CodeNQW  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-23
Decision Date2015-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10889981076047 K150469 000
10889981075781 K150469 000
10889981075804 K150469 000
10889981075828 K150469 000
10889981075873 K150469 000
10889981075897 K150469 000
10889981075910 K150469 000
10889981075934 K150469 000
10889981075989 K150469 000
10889981076009 K150469 000
10889981076023 K150469 000
10889981075767 K150469 000

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