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FDA 510(k) Application Details - K062513
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K062513
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
SPINECRAFT, INC.
2215 ENTERPRISE DRIVE
SUITE 1504
WESTCHESTER, IL 60154 US
Other 510(k) Applications for this Company
Contact
AMI AKALLAL-ASAAD
Other 510(k) Applications for this Contact
Regulation Number
888.3050
More FDA Info for this Regulation Number
Classification Product Code
KWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/2006
Decision Date
12/22/2006
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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