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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, Cervical
510(k) Number K181471
Device Name ACCUFUSE Cervical System
Applicant
Absolute Advantage Medical, LLC
2731 Millbrook Rd.
Fayetteville,  NC  78681
Applicant Contact J.D. Webb
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J.D. Webb
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
KWQ  
Date Received06/04/2018
Decision Date 08/29/2018
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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