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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K181397
Device Name DualX
Applicant
Innovasive, Inc.
26020 Acero, Suite 200
Mission Viejo,  CA  92691
Applicant Contact Andy Choi
Correspondent
Empirical Consulting
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith L. May
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/29/2018
Decision Date 09/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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