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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K183091
Device Name Elaris Pedicle Screw System
Applicant
Spinewelding AG
Wagistrasse 6
Schlieren,  CH 8952
Applicant Contact Joerg Mayer
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3070
Classification Product Code
NKB  
Date Received11/06/2018
Decision Date 08/02/2019
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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