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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 K941941
Device Name BONE MULCH SCREW
Applicant
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46580
Applicant Contact MARY L VERSTYNEN
Correspondent
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46580
Correspondent Contact MARY L VERSTYNEN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/21/1994
Decision Date 02/02/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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