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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 K991732
Device Name CENTRAFIX EXTERNAL FIXATOR
Applicant
Owandar Medical, Ltd.
P.O. Box 389
High Wycombe
Hp14 3xp,  GB
Applicant Contact JOHN RADWELL
Correspondent
Owandar Medical, Ltd.
P.O. Box 389
High Wycombe
Hp14 3xp,  GB
Correspondent Contact JOHN RADWELL
Regulation Number888.3040
Classification Product Code
JEC  
Date Received05/21/1999
Decision Date 05/21/1999
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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