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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 K960940
Device Name BIOSCREW ABSORBABLE INTERFERENCE SCREW
Original Applicant
LINVATEC CORP.
11311 concept blvd.
largo,  FL  33773 4908
Original Contact carol a weideman, ph.d.
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
MAI   MNU  
Date Received03/08/1996
Decision Date 08/15/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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