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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 K013888
Device Name FIXATION (STEINMANN) PINS
Applicant
Miltex, Inc.
700 Hicksville Rd.
Bethpage,  NY  11714
Applicant Contact RICHARD GORDON
Correspondent
Miltex, Inc.
700 Hicksville Rd.
Bethpage,  NY  11714
Correspondent Contact RICHARD GORDON
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
IDW  
Date Received11/23/2001
Decision Date 05/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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