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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K031155
Device Name OSTEOMED SUBTALAR IMPLANT SYSTEM
Applicant
Osteomed LP
3885 Arapaho Rd.
Addison,  TX  75001
Applicant Contact DAWN T HOLDEMAN
Correspondent
Osteomed LP
3885 Arapaho Rd.
Addison,  TX  75001
Correspondent Contact DAWN T HOLDEMAN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/11/2003
Decision Date 08/22/2003
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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