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FDA 510(k) Application Details - K160003
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K160003
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
SPINE WAVE, INC.
3 ENTERPRISE DRIVE
SUITE 210
SHELTON, CT 06484 US
Other 510(k) Applications for this Company
Contact
KELLY Barbieri
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/04/2016
Decision Date
02/26/2016
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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