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FDA 510(k) Application Details - K202812
Device Classification Name
More FDA Info for this Device
510(K) Number
K202812
Device Name
IdentiTi Cervical Standalone Interbody System
Applicant
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008 US
Other 510(k) Applications for this Company
Contact
Ruby Zheng
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/2020
Decision Date
12/18/2020
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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