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FDA 510(k) Application Details - K062151
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K062151
Device Name
Spinal Vertebral Body Replacement Device
Applicant
INNOVASIS, INC.
614 EAST 3900 SOUTH
SALT LAKE CITY, UT 84107 US
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Contact
WARREN M DANSIE
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
07/27/2006
Decision Date
12/22/2006
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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