Polaris Spinal System

Thoracolumbosacral Pedicle Screw System

Zimmer Biomet Spine, Inc

The following data is part of a premarket notification filed by Zimmer Biomet Spine, Inc with the FDA for Polaris Spinal System.

Pre-market Notification Details

Device IDK210275
510k NumberK210275
Device Name:Polaris Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Zimmer Biomet Spine, Inc 10225 Westmoor Drive Westminster,  CO  80021
ContactAnjanet Mort
CorrespondentAnjanet Mort
Zimmer Biomet Spine, Inc 10225 Westmoor Drive Westminster,  CO  80021
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-01
Decision Date2021-04-02

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