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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K992367
Device Name EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS
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 Number888.3040
Classification Product Code
HWC  
Date Received07/15/1999
Decision Date 09/23/1999
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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