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FDA 510(k) Application Details - K102885
Device Classification Name
Component, Traction, Invasive
More FDA Info for this Device
510(K) Number
K102885
Device Name
Component, Traction, Invasive
Applicant
STRYKER CORP.
325 Corporate Drive
Mahwah, NJ 07430 US
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Contact
ZAMIR BAR-DAVID
Other 510(k) Applications for this Contact
Regulation Number
888.3040
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Classification Product Code
JEC
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More FDA Info for this Product Code
Date Received
09/30/2010
Decision Date
01/14/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K102885
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