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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 K970829
Device Name PHUSIS ABSORBABLE INTERFERENCE SCREW
Applicant
TORNIER
1000 BURNETT AVE.
SUITE 450
CONCORD,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
TORNIER
1000 BURNETT AVE.
SUITE 450
CONCORD,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received03/06/1997
Decision Date 12/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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