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510(k) K251575

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System by Alphatec Spine — Product Code OVD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2025
Date Received
May 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

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