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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 K090064
Device Name EMINENT SPINE INTERBODY FUSION SYSTEM
Applicant
Eminent Spine
16001 Ronald Reagan Blvd.
Leander,  TX  78641
Applicant Contact DAVE FREEHILL
Correspondent
Eminent Spine
16001 Ronald Reagan Blvd.
Leander,  TX  78641
Correspondent Contact DAVE FREEHILL
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP  
Date Received01/09/2009
Decision Date 04/09/2009
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
Recalls CDRH Recalls
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