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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, Lumbar
510(k) Number K122021
Device Name STERISPINE LC CAGE
Applicant
Safe Orthopaedics
Parc Des Bellevues- Allee
R Luxembourg
Eragny Sur Oise,  FR 95610
Applicant Contact P. DUMOUCHEL
Correspondent
Safe Orthopaedics
Parc Des Bellevues- Allee
R Luxembourg
Eragny Sur Oise,  FR 95610
Correspondent Contact P. DUMOUCHEL
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/10/2012
Decision Date 09/20/2012
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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