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FDA 510(k) Application Details - K041382
Device Classification Name
Prosthesis, Hip, Cement Restrictor
More FDA Info for this Device
510(K) Number
K041382
Device Name
Prosthesis, Hip, Cement Restrictor
Applicant
OSTEOBIOLOGICS, INC.
12500 NETWORK
SUITE 112
SAN ANTONIO, TX 78249 US
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Contact
GABRIELE G NIEDERAUER, PH.D.
Other 510(k) Applications for this Contact
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
05/25/2004
Decision Date
06/17/2005
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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