Align Lumbar Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Lumbar

Acuity Surgical Devices, LLC

The following data is part of a premarket notification filed by Acuity Surgical Devices, Llc with the FDA for Align Lumbar Interbody Fusion System.

Pre-market Notification Details

Device IDK221535
510k NumberK221535
Device Name:Align Lumbar Interbody Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Acuity Surgical Devices, LLC 8710 N. Royal Lane Irving,  TX  75063
ContactBryan Cowan
CorrespondentCharlie Forton
Acuity Surgical Devices, LLC 8710 N. Royal Lane Irving,  TX  75063
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-27
Decision Date2022-07-22

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