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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K925447
Device Name OTI ORTHOPEDIC WIRE SYSTEM
Applicant
Osteo Technology, Inc.
10 W. Aylesbury Rd.
Timonium,  MD  21093
Applicant Contact SAM SON
Correspondent
Osteo Technology, Inc.
10 W. Aylesbury Rd.
Timonium,  MD  21093
Correspondent Contact SAM SON
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received10/28/1992
Decision Date 06/29/1993
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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