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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 K972233
Device Name STRYKER WEDGE INTERFERENCE SCREW SYSTEM
Original Applicant
STRYKER ENDOSCOPY
2590 walsh ave.
santa clara,  CA  95051 4085
Original Contact douglas m lorang
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/16/1997
Decision Date 08/05/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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