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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 K962233
Device Name TWIST-OFF SCREW
Applicant
Landos, Inc.
9109 Copenhaver Dr.
Potomac,  MD  20854
Applicant Contact NORMAN F ESTRIN
Correspondent
Landos, Inc.
9109 Copenhaver Dr.
Potomac,  MD  20854
Correspondent Contact NORMAN F ESTRIN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/11/1996
Decision Date 10/03/1996
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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