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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K890902
Device Name BIOFIX* BIODEGRADABLE FIXATION ROD
Applicant
Davis & Geck, Inc.
American Cynamid Company
One Casper St.
Danbury,  CT  06810
Applicant Contact R. I PELLETIER
Correspondent
Davis & Geck, Inc.
American Cynamid Company
One Casper St.
Danbury,  CT  06810
Correspondent Contact R. I PELLETIER
Regulation Number888.3040
Classification Product Code
HTY  
Date Received02/22/1989
Decision Date 11/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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