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510(k) K161710

SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL by Spinal Analytics & Geometrical Impant Co, LLC — Product Code MAX

K161710 is an FDA 510(k) premarket notification submitted by Spinal Analytics & Geometrical Impant Co, LLC for the device "SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL". The FDA issued a decision of Substantially Equivalent on Jun 29, 2017. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 29, 2017
Date Received
Jun 21, 2016
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
510(k)

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

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FDA data resources