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FDA 510(k) Application Details - K011887
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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510(K) Number
K011887
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant
ORTHOPEDIC SOURCE INC.
PO BOX 307
LOOMIS, CA 95650 US
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Contact
STEVEN L MANDELL
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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
06/18/2001
Decision Date
12/27/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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