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FDA 510(k) Application Details - K143490
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K143490
Device Name
Spinal Vertebral Body Replacement Device
Applicant
CAMBER SPINE
418 E. Lancaster Ave.
Wayne, PA 19087 US
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Contact
Daniel A. Pontecorvo
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
12/08/2014
Decision Date
01/26/2015
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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