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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 K970912
Device Name LEIBINGER SELF-DRILLING SCREW
Applicant
Howmedica Leibinger, Inc.
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Applicant Contact KRISTYN WASKI
Correspondent
Howmedica Leibinger, Inc.
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Correspondent Contact KRISTYN WASKI
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/12/1997
Decision Date 10/01/1997
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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