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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 K100544
Device Name IMPIX LUMBAR INTERBODY DEVICE
Applicant
MEDICREA TECHNOLOGIES
1001 OAKWOOD BLVD.
ROUND ROCK,  TX  78681
Applicant Contact JD WEBB
Correspondent
MEDICREA TECHNOLOGIES
1001 OAKWOOD BLVD.
ROUND ROCK,  TX  78681
Correspondent Contact JD WEBB
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/25/2010
Decision Date 07/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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