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510(k) K190600

ORION Spinal System by Orion Biotech, Inc. — Product Code NKB

K190600 is an FDA 510(k) premarket notification submitted by Orion Biotech, Inc. for the device "ORION Spinal System". The FDA issued a decision of Substantially Equivalent on Aug 18, 2020. 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
Aug 18, 2020
Date Received
Mar 8, 2019
Clearance Type
Abbreviated
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