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FDA 510(k) Application Details - K081205
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K081205
Device Name
Cerclage, Fixation
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER, PA 19380 US
Other 510(k) Applications for this Company
Contact
KARL J NITTINGER
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
04/29/2008
Decision Date
07/01/2008
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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