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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K060522
Device Name SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
Applicant
Scandius Biomedical, Inc.
11a Beaver Brook Rd.
Littleton,  MA  01460
Applicant Contact ERIC BANNON
Correspondent
Scandius Biomedical, Inc.
11a Beaver Brook Rd.
Littleton,  MA  01460
Correspondent Contact ERIC BANNON
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received02/27/2006
Decision Date 04/11/2006
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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