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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 K010964
Device Name AUTO-DRIVE LAG 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 Received03/30/2001
Decision Date 07/05/2001
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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