Altus Spine Sochi OCT Spinal System

Posterior Cervical 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 Sochi Oct Spinal System.

Pre-market Notification Details

Device IDK210887
510k NumberK210887
Device Name:Altus Spine Sochi OCT Spinal System
ClassificationPosterior Cervical Screw System
Applicant Altus Partners, LLC 1340 Enterprise Drive West Chester,  PA  19380
ContactMark Melton
CorrespondentMark Melton
Altus Partners, LLC 1340 Enterprise Drive West Chester,  PA  19380
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-25
Decision Date2021-08-20

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