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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 K050497
Device Name BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773 -4908
Applicant Contact ELIZABETH PAUL
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773 -4908
Correspondent Contact ELIZABETH PAUL
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/28/2005
Decision Date 03/25/2005
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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