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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 K110177
Device Name HELENA SYSTEM
Applicant
ROYAL OAK MEDICAL DEVICES
39533 WOODWARD AVENUE
BLOOMFIELD HILLS,  MI  48304
Applicant Contact MATTHEW KROLL
Correspondent
ROYAL OAK MEDICAL DEVICES
39533 WOODWARD AVENUE
BLOOMFIELD HILLS,  MI  48304
Correspondent Contact MATTHEW KROLL
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/21/2011
Decision Date 04/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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