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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 K023260
Device Name 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
Applicant
OSTEOMED CORP.
3750 REALTY RD.
ADDISON,  TX  75001 -4311
Applicant Contact DAWN T HOLDEMAN
Correspondent
OSTEOMED CORP.
3750 REALTY RD.
ADDISON,  TX  75001 -4311
Correspondent Contact DAWN T HOLDEMAN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/30/2002
Decision Date 10/18/2002
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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