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FDA 510(k) Application Details - K143085
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
More FDA Info for this Device
510(K) Number
K143085
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant
STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah, NJ 07430 US
Other 510(k) Applications for this Company
Contact
Denise Daugert
Other 510(k) Applications for this Contact
Regulation Number
888.3358
More FDA Info for this Regulation Number
Classification Product Code
LPH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/27/2014
Decision Date
02/09/2015
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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