Sniper Spine System

Orthosis, Spinal Pedicle Fixation

SPINE WAVE, INC.

The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Sniper Spine System.

Pre-market Notification Details

Device IDK151813
510k NumberK151813
Device Name:Sniper Spine System
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SPINE WAVE, INC. 3 ENTERPRISE DRIVE, SUITE 210 Shelton,  CT  06484
ContactRonald K Smith
CorrespondentRonald K Smith
SPINE WAVE, INC. 3 ENTERPRISE DRIVE, SUITE 210 Shelton,  CT  06484
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-02
Decision Date2015-07-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10840642106237 K151813 000

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