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510(k) K201457

Auxein Brand Vertaux 5.5 mm Pedicle Screw System by Auxein Medical Private Limited/71164 — Product Code NKB

K201457 is an FDA 510(k) premarket notification submitted by Auxein Medical Private Limited/71164 for the device "Auxein Brand Vertaux 5.5 mm Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on Apr 6, 2021. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 6, 2021
Date Received
Jun 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type
510(k)

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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FDA data resources