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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 K150455
Device Name RT2 Trabeculite Titanium Cervical Cage System
Applicant
Rhausler, Inc.
837 Industrial Rd., Unit E
San Carlos,  CA  94070
Applicant Contact TERRY JOHNSTON
Correspondent
Dionicia Reblando
837 Industrial Rd., Unit E
San Carlos,  CA  94070
Correspondent Contact DIONICIA REBLANDO
Regulation Number888.3080
Classification Product Code
ODP  
Date Received02/20/2015
Decision Date 11/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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