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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 K935383
Device Name FEMROD AND FEMROD RECON INSERT
Applicant
Applied Osteo Systems, Inc.
1243 Alpine Rd.
Suite 221
Walnut Creek,  CA  94596
Applicant Contact SCOTT HUNTLEY
Correspondent
Applied Osteo Systems, Inc.
1243 Alpine Rd.
Suite 221
Walnut Creek,  CA  94596
Correspondent Contact SCOTT HUNTLEY
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/08/1993
Decision Date 03/21/1995
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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