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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intraoperative Orthopedic Joint Assessment Aid
510(k) Number K093046
Device Name ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
Applicant
Synvasive Technology, Inc.
8726 Ferrara Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
Synvasive Technology, Inc.
8726 Ferrara Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number882.4560
Classification Product Code
ONN  
Date Received09/30/2009
Decision Date 03/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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