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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K902264
Device Name TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY
Applicant
Applied Osteo Systems, Inc.
4 Willow Spring Ln.
Moraga,  CA  94556
Applicant Contact MICHAEL PENTOPOULOS
Correspondent
Applied Osteo Systems, Inc.
4 Willow Spring Ln.
Moraga,  CA  94556
Correspondent Contact MICHAEL PENTOPOULOS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/21/1990
Decision Date 07/12/1990
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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