FDA.reportPublic FDA data

510(k) K232097

Device
IdentiTi ALIF Interbody Systems
Applicant
Alphatec Spine, Inc.
510(k) number
K232097
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-25
Date received
2023-07-13
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Andrew Zhang
Address
1950 Camino Vida Roble Carlsbad CA US 92008 92008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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