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510(k) K173864

Peekplus® Interbody Fusion Device by Vallum Corporation — Product Code MAX

K173864 is an FDA 510(k) premarket notification submitted by Vallum Corporation for the device "Peekplus® Interbody Fusion Device". The FDA issued a decision of Substantially Equivalent on Jul 2, 2018. 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
Jul 2, 2018
Date Received
Dec 20, 2017
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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  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
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FDA data resources