DualX

Intervertebral Fusion Device With Bone Graft, Lumbar

Amplify Surgical, Inc.

The following data is part of a premarket notification filed by Amplify Surgical, Inc. with the FDA for Dualx.

Pre-market Notification Details

Device IDK211740
510k NumberK211740
Device Name:DualX
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Amplify Surgical, Inc. 9272 Jeronimo Rd Suite 107B Irvine,  CA  92618
ContactAndy Choi
CorrespondentMeredith May
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-07
Decision Date2021-09-29

Trademark Results [DualX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DUALX
DUALX
87198136 5788186 Live/Registered
IMDS, LLC
2016-10-10

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