Leva(TM) Spacer System

Intervertebral Fusion Device With Bone Graft, Lumbar

SPINE WAVE, INC.

The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Leva(tm) Spacer System.

Pre-market Notification Details

Device IDK150285
510k NumberK150285
Device Name:Leva(TM) Spacer System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SPINE WAVE, INC. 3 ENTERPRISE DRIVE SUITE 210 Shelton,  CT  06484
ContactRoaida Johnson
CorrespondentRoaida Johnson
SPINE WAVE, INC. 3 ENTERPRISE DRIVE SUITE 210 Shelton,  CT  06484
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-05
Decision Date2015-03-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10840642100358 K150285 000
10840642100341 K150285 000
10840642100334 K150285 000
10840642100327 K150285 000
10840642100310 K150285 000

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