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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 K803166
Device Name DOUBLE BALL JOINT
Applicant
Howmedica Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Howmedica Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3040
Classification Product Code
JEC  
Date Received12/15/1980
Decision Date 01/09/1981
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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