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FDA 510(k) Application Details - K170444
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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510(K) Number
K170444
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant
MicroPort Orthopedics Inc
5677 Airline Road
Arlington, TN 38002 US
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Contact
Kaitlin Grove
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Regulation Number
888.3358
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Classification Product Code
LPH
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More FDA Info for this Product Code
Date Received
02/14/2017
Decision Date
06/26/2017
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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