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510(k) K202820

Australis Anterior Lumbar Cage System by Prism Surgical Designs Pty, Ltd. — Product Code MAX

K202820 is an FDA 510(k) premarket notification submitted by Prism Surgical Designs Pty, Ltd. for the device "Australis Anterior Lumbar Cage System". The FDA issued a decision of Substantially Equivalent on Dec 22, 2020. 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
Dec 22, 2020
Date Received
Sep 24, 2020
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