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FDA 510(k) Application Details - K960258
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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510(K) Number
K960258
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN, TX 78717 US
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Contact
JACQUELYN HUGHES
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Regulation Number
888.3350
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Classification Product Code
JDI
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More FDA Info for this Product Code
Date Received
01/18/1996
Decision Date
07/12/1996
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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