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FDA 510(k) Application Details - K010241
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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510(K) Number
K010241
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant
STELKAST COMPANY
800 VINIAL ST. #210
PITTSBURGH, PA 15212 US
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Contact
DONALD A STEVENS
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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
01/25/2001
Decision Date
02/08/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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