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FDA 510(k) Application Details - K022793
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K022793
Device Name
Spinal Vertebral Body Replacement Device
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
888.3060
More FDA Info for this Regulation Number
Classification Product Code
MQP
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More FDA Info for this Product Code
Date Received
08/23/2002
Decision Date
04/08/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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