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FDA 510(k) Application Details - K040199
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K040199
Device Name
Cerclage, Fixation
Applicant
OSSEUS, LLC
3131 PRINCETON PIKE
BLDG. 5, SUITE 200
LAWRENCEVILLE, NJ 08648 US
Other 510(k) Applications for this Company
Contact
SHAWN T HUXEL
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
01/29/2004
Decision Date
02/20/2004
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
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