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510(k) K192006

SIRION Lateral Lumbar Interbody System by Astura Medical, LLC — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2020
Date Received
July 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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