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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 K183447
Device Name EIT Cellular Titanium Lumbar Cage - T/PLIF
Applicant
Eit Emerging Implant Technologies GmbH
Eisenbahnstrasse 84
Wurmlingen,  DE 78573
Applicant Contact Barbara Wirth
Correspondent
Eit Emerging Implant Technologies GmbH
Eisenbahnstrasse 84
Wurmlingen,  DE 78573
Correspondent Contact Barbara Wirth
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/12/2018
Decision Date 02/04/2019
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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