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FDA 510(k) Application Details - K023647
Device Classification Name
Prosthesis, Hip, Cement Restrictor
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510(K) Number
K023647
Device Name
Prosthesis, Hip, Cement Restrictor
Applicant
SPINAL CONCEPTS, INC.
12012 TECHNOLOGY BLVD., #100
AUSTIN, TX 78727 US
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Contact
AUDREY SWEARINGEN
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Regulation Number
878.3300
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Classification Product Code
JDK
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More FDA Info for this Product Code
Date Received
10/30/2002
Decision Date
11/27/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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