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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 K944213
Device Name 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
Applicant
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Applicant Contact ROBERT E SMITH
Correspondent
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Correspondent Contact ROBERT E SMITH
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/29/1994
Decision Date 12/09/1994
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
Predetermined Change
Control Plan Authorized		 No
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