Golden Isles Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Intelivation LLC

The following data is part of a premarket notification filed by Intelivation Llc with the FDA for Golden Isles Pedicle Screw System.

Pre-market Notification Details

Device IDK212185
510k NumberK212185
Device Name:Golden Isles Pedicle Screw System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Intelivation LLC 70 Gruber Lane Saint Simons Island,  GA  31522
ContactAmit Sinha
CorrespondentBarry Sands
RQMIS, Inc. 110 Haverhill Road, Suite 524 Amesbury,  MA  01913
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-13
Decision Date2021-08-19

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.