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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 K071157
Device Name STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS
Original Applicant
STRYKER ENDOSCOPY
5900 optical ct.
san jose,  CA  95138
Original Contact jeff semone
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
JDR   MBI  
Date Received04/26/2007
Decision Date 09/17/2007
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
Recalls CDRH Recalls
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