Altus Spine Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Altus Partners, LLC

The following data is part of a premarket notification filed by Altus Partners, Llc with the FDA for Altus Spine Pedicle Screw System.

Pre-market Notification Details

Device IDK211027
510k NumberK211027
Device Name:Altus Spine Pedicle Screw System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Altus Partners, LLC 1340 Enterprise Drive West Chester,  PA  19380
ContactMark Melton
CorrespondentRand Baker
Altus Partners, LLC 1340 Enterprise Drive West Chester,  PA  19380
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-06
Decision Date2022-09-16

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