ABACUS 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 Abacus Tm Spacer System.

Pre-market Notification Details

Device IDK140007
510k NumberK140007
Device Name:ABACUS TM SPACER SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton,  CT  06484
ContactJoseph Mercado
CorrespondentJoseph Mercado
SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton,  CT  06484
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-02
Decision Date2014-04-07
Summary:summary

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