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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K813554
Device Name ACE/KYLE CAPTURED HIP SCREW
Applicant
Ace Orthopedic Manufacturing Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ace Orthopedic Manufacturing Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3030
Classification Product Code
KTT  
Date Received12/22/1981
Decision Date 01/12/1982
Decision Substantially Equivalent (SESE)
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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