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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 K080588
Device Name SCIENT'X TRIBECA VBR
Applicant
Scient'X USA, Inc.
1015 Maitland Center Commons
Suite 106a
Maitland,  FL  32751
Applicant Contact JOHN SANDERS
Correspondent
Scient'X USA, Inc.
1015 Maitland Center Commons
Suite 106a
Maitland,  FL  32751
Correspondent Contact JOHN SANDERS
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/03/2008
Decision Date 05/30/2008
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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