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FDA 510(k) Application Details - K153603
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K153603
Device Name
Orthopedic Stereotaxic Instrument
Applicant
ALPHATEC SPINE, INC.
5818 EL CAMINO REAL
CARLSBAD, CA 92008 US
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RENEE MURPHY
Other 510(k) Applications for this Contact
Regulation Number
882.4560
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Classification Product Code
OLO
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More FDA Info for this Product Code
Date Received
12/17/2015
Decision Date
04/29/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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