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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 K082801
Device Name PHANTOM PLUS CAGE SYSTEM
Applicant
US SPINE
3600 FAU BLVD.
SUITE 101
BOCA RATON,  FL  33431
Applicant Contact PETER HARRIS
Correspondent
US SPINE
3600 FAU BLVD.
SUITE 101
BOCA RATON,  FL  33431
Correspondent Contact PETER HARRIS
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received09/24/2008
Decision Date 12/22/2008
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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