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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 K013131
Device Name BIOSCREW XTRALOK
Applicant
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Applicant Contact LAURA D SENEFF
Correspondent
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Correspondent Contact LAURA D SENEFF
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/19/2001
Decision Date 06/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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