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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 K971069
Device Name TWIST-OFF (TM) SCREW
Applicant
Landos, Inc.
101 Lindenwood Dr.,Suite 110
Malvern,  PA  19355
Applicant Contact KATH LAFFAN
Correspondent
Landos, Inc.
101 Lindenwood Dr.,Suite 110
Malvern,  PA  19355
Correspondent Contact KATH LAFFAN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/24/1997
Decision Date 07/09/1997
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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