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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K990999
Device Name MODIFICATION OF: EBI SPINELINK SYSTEM
Applicant
Electro-Biology, Inc.
100 Interpace Pkwy.
Parsippany,  NJ  07054
Applicant Contact JONAS WILF
Correspondent
Electro-Biology, Inc.
100 Interpace Pkwy.
Parsippany,  NJ  07054
Correspondent Contact JONAS WILF
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received03/25/1999
Decision Date 04/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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