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FDA 510(k) Application Details - K092825
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K092825
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
SPINECRAFT, INC.
2215 ENTREPRISE DR.
WESTCHESTER, IL 60154-5804 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
09/11/2009
Decision Date
03/16/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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