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FDA 510(k) Application Details - K071271
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K071271
Device Name
Cerclage, Fixation
Applicant
BIOMET MANUFACTURING, INC.
P.O. BOX 587
WARSAW, IN 46581-0578 US
Other 510(k) Applications for this Company
Contact
BECKY EARL
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
05/07/2007
Decision Date
10/23/2007
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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