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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 K102449
Device Name BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM
Applicant
Bright Spine, Inc.
799 NE 71st St.
Boca Raton,  FL  33487
Applicant Contact ROBERT SIMONSON
Correspondent
Bright Spine, Inc.
799 NE 71st St.
Boca Raton,  FL  33487
Correspondent Contact ROBERT SIMONSON
Regulation Number888.3080
Classification Product Code
ODP  
Date Received08/27/2010
Decision Date 02/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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