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FDA 510(k) Application Details - K170055
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K170055
Device Name
Spinal Vertebral Body Replacement Device
Applicant
K2M
600 Hope Parkway SE
Leesburg, VA 20175 US
Other 510(k) Applications for this Company
Contact
Nancy Giezen
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
MQP
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More FDA Info for this Product Code
Date Received
01/06/2017
Decision Date
04/13/2017
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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