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FDA 510(k) Application Details - K100685
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K100685
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
ALPHATEC SPINE, INC.
5818 EL CAMINO REAL
CARLSBAD, CA 92008 US
Other 510(k) Applications for this Company
Contact
CHERYL ALLEN
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
03/10/2010
Decision Date
06/18/2010
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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