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FDA 510(k) Application Details - K080349
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K080349
Device Name
Spinal Vertebral Body Replacement Device
Applicant
SIGNUS MEDIZINTECHNIK GMBH
4050 OLSON MEMORIAL HWY
SUITE 350
MINNEAPOLIS, MN 55422 US
Other 510(k) Applications for this Company
Contact
ALAN ALEXANDER
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
MQP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/11/2008
Decision Date
03/10/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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