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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 K973758
Device Name BIOSCREW ABSORBABLE INTERFERENCE SREW
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773 -4908
Applicant Contact CAROL A WEIDEMAN
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773 -4908
Correspondent Contact CAROL A WEIDEMAN
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received10/02/1997
Decision Date 02/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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