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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, Intraosseous
510(k) Number K002423
Device Name LACTOSORB PUSH SCREW
Applicant
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact TRACY BICKEL
Correspondent
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact TRACY BICKEL
Regulation Number872.4880
Classification Product Code
DZL  
Date Received08/08/2000
Decision Date 10/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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