MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM

Fastener, Fixation, Nondegradable, Soft Tissue

SCANDIUS BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Scandius Biomedical, Inc. with the FDA for Modification To Scandius Tritis Tibial Acl Reconstruction System.

Pre-market Notification Details

Device IDK063499
510k NumberK063499
Device Name:MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant SCANDIUS BIOMEDICAL, INC. 11A BEAVER BROOK ROAD Littleton,  MA  01460
ContactRalph Zimmerman
CorrespondentRalph Zimmerman
SCANDIUS BIOMEDICAL, INC. 11A BEAVER BROOK ROAD Littleton,  MA  01460
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-20
Decision Date2006-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521514119 K063499 000
10884521513990 K063499 000

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