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 IDK152174
510k NumberK152174
Device Name:Sniper Spine System
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SPINE WAVE, INC. 3 ENTERPRISE DRIVE, SUITE 210 Shelton,  CT  06484
ContactSanja Jahr
CorrespondentSanja Jahr
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 Received2015-08-04
Decision Date2015-08-31
Summary:summary

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