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FDA 510(k) Application Details - K101288
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K101288
Device Name
Spinal Vertebral Body Replacement Device
Applicant
SPINE WAVE, INC.
THREE ENTERPRISE DR.
SUITE 210
SHELTON, CT 06484 US
Other 510(k) Applications for this Company
Contact
ROAIDA RIZKALLAH
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
05/07/2010
Decision Date
09/10/2010
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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