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FDA 510(k) Application Details - K103797
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K103797
Device Name
Cerclage, Fixation
Applicant
K2M, INC.
751 MILLER DR.,SE
LEESBURG, VA 20175 US
Other 510(k) Applications for this Company
Contact
NANCY GIEZEN
Other 510(k) Applications for this Contact
Regulation Number
888.3010
More FDA Info for this Regulation Number
Classification Product Code
JDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/27/2010
Decision Date
05/20/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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