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FDA 510(k) Application Details - K161080
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
More FDA Info for this Device
510(K) Number
K161080
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant
ORTHO DEVELOPMENT CORPORATION
12187 SOUTH BUSINESS PARK DRIVE
DRAPER, UT 84020 US
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Contact
Drew Weaver
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
04/18/2016
Decision Date
05/17/2016
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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