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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
Recalls CDRH Recalls
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