InFill Graft Delivery System

Syringe, Piston

PINNACLE SPINE GROUP, LLC

The following data is part of a premarket notification filed by Pinnacle Spine Group, Llc with the FDA for Infill Graft Delivery System.

Pre-market Notification Details

Device IDK143488
510k NumberK143488
Device Name:InFill Graft Delivery System
ClassificationSyringe, Piston
Applicant PINNACLE SPINE GROUP, LLC 1601 ELM STREET, SUITE 300 Dallas,  TX  75201
ContactRebecca K Pine
CorrespondentRebecca K Pine
PINNACLE SPINE GROUP, LLC 1601 ELM STREET, SUITE 300 Dallas,  TX  75201
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-08
Decision Date2014-12-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814729026155 K143488 000

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