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FDA 510(k) Application Details - K020836
Device Classification Name
Prosthesis, Hip, Cement Restrictor
More FDA Info for this Device
510(K) Number
K020836
Device Name
Prosthesis, Hip, Cement Restrictor
Applicant
SIGNUS MEDICAL LLC.
4050 OLSON MEMORIAL HIGHWAY
SUITE 350
MINNEAPOLIS, MN 55422 US
Other 510(k) Applications for this Company
Contact
ANN QUINLAN-SMITH
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
JDK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/14/2002
Decision Date
06/11/2002
Decision
SESE - SUBST EQUIV
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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