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FDA 510(k) Application Details - K232097
Device Classification Name
More FDA Info for this Device
510(K) Number
K232097
Device Name
IdentiTi ALIF Interbody Systems
Applicant
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad, CA 92008 US
Other 510(k) Applications for this Company
Contact
Andrew Zhang
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/13/2023
Decision Date
09/25/2023
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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