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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 K922766
Device Name ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
Applicant
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact JEFFREY HENDERSON
Correspondent
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact JEFFREY HENDERSON
Regulation Number888.3040
Classification Product Code
HTY  
Date Received06/02/1992
Decision Date 07/09/1993
Decision Substantially Equivalent - Kit (SESK)
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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