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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 K140348
Device Name INTERBODY CAGE
Applicant
Eisertech, LLC
1133 Columbia St.
Suite 107
San Diego,  CA  92101
Applicant Contact LUKAS EISERMANN
Correspondent
Eisertech, LLC
1133 Columbia St.
Suite 107
San Diego,  CA  92101
Correspondent Contact LUKAS EISERMANN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/11/2014
Decision Date 04/23/2015
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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