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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 K033252
Device Name MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
Applicant
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Applicant Contact MELISSA MURPHY
Correspondent
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Correspondent Contact MELISSA MURPHY
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received10/08/2003
Decision Date 11/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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