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FDA 510(k) Application Details - K142996
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K142996
Device Name
Spinal Vertebral Body Replacement Device
Applicant
SPINE WAVE, INC.
3 ENTERPRISE DRIVE
SUITE 210
SHELTON, CT 06484 US
Other 510(k) Applications for this Company
Contact
Roaida Johnson
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
10/16/2014
Decision Date
02/19/2015
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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