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FDA 510(k) Application Details - K143184
Device Classification Name
Prosthesis, Hip, Hemi-, Femoral, Metal
More FDA Info for this Device
510(K) Number
K143184
Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Applicant
Signature Orthopaedics Pty Ltd.
7 Sirius Road
Lane Cove 2066 AU
Other 510(k) Applications for this Company
Contact
Declan Brazil
Other 510(k) Applications for this Contact
Regulation Number
888.3360
More FDA Info for this Regulation Number
Classification Product Code
KWL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/05/2014
Decision Date
03/17/2015
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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