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510(k) K230766

Altus Spine Monaco Pedicle Screw System by Altus Spine — Product Code NKB

K230766 is an FDA 510(k) premarket notification submitted by Altus Spine for the device "Altus Spine Monaco Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on Apr 19, 2023. 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 19, 2023
Date Received
Mar 20, 2023
Clearance Type
Special
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