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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 K934366
Device Name MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
Applicant
Mitek Surgical Products, Inc.
57 Providence Hwy.
Norwood,  MA  02062
Applicant Contact ROBERT P ZOLETTI
Correspondent
Mitek Surgical Products, Inc.
57 Providence Hwy.
Norwood,  MA  02062
Correspondent Contact ROBERT P ZOLETTI
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
JDW  
Date Received09/07/1993
Decision Date 10/07/1994
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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