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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K781839
Device Name BONE CLAMP, ACE EXTERNAL
Applicant
Ace Orthopedic Manufacturing Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ace Orthopedic Manufacturing Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3040
Classification Product Code
JEC  
Date Received10/27/1978
Decision Date 11/08/1978
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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