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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, Threaded
510(k) Number K961920
Device Name CROSS PIN
Applicant
Medicinelodge, Inc.
152 S. 600 W.
Logan,  UT  84321
Applicant Contact WADE FALLIN
Correspondent
Medicinelodge, Inc.
152 S. 600 W.
Logan,  UT  84321
Correspondent Contact WADE FALLIN
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
HTY  
Date Received05/17/1996
Decision Date 09/17/1996
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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