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FDA 510(k) Application Details - K091743
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K091743
Device Name
Spinal Vertebral Body Replacement Device
Applicant
INNVOTEC SURGICAL, INC.
1331 H STREET NW
12TH FLOOR
WASHINGTON, DC 20005 US
Other 510(k) Applications for this Company
Contact
JUSTIN EGGLETON
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
MQP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2009
Decision Date
11/02/2009
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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