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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 K100889
Device Name ENDOSKELETON TC
Applicant
Titan Spine, LLC
555 13th St., NW
Washington,  DC  20004
Applicant Contact JOHN J SMITH
Correspondent
Titan Spine, LLC
555 13th St., NW
Washington,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number888.3080
Classification Product Code
ODP  
Date Received03/31/2010
Decision Date 07/29/2010
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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