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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K964533
Device Name EBI SPINELINK SYSTEM
Applicant
Electro-Biology, Inc.
6 Upper Pond Rd.
P.O. Box 345
Parsippany,  NJ  07054
Applicant Contact SHARON A STAROWICZ
Correspondent
Electro-Biology, Inc.
6 Upper Pond Rd.
P.O. Box 345
Parsippany,  NJ  07054
Correspondent Contact SHARON A STAROWICZ
Regulation Number888.3070
Classification Product Code
MNH  
Date Received11/12/1996
Decision Date 04/09/1997
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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