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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K013557
Device Name LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
Applicant
Walter Lorenz Surgical, Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact TRACY J BICKEL
Correspondent
Walter Lorenz Surgical, Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact TRACY J BICKEL
Regulation Number888.3040
Classification Product Code
MBI  
Date Received10/24/2001
Decision Date 11/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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