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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 K170503
Device Name EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages
Applicant
Eit Emerging Implant Technologies GmbH
Eisenbahnstrasse 84
Wurmlingen,  DE 78573
Applicant Contact Barbara Wirth
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K St. NW, 10th Floor
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received02/21/2017
Decision Date 07/11/2017
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
Recalls CDRH Recalls
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