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510(k) K232996

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) by Shanghai Iatrical-Ti Technologies CO , Ltd. — Product Code MAX

K232996 is an FDA 510(k) premarket notification submitted by Shanghai Iatrical-Ti Technologies CO , Ltd. for the device "Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)". The FDA issued a decision of Substantially Equivalent on September 6, 2024. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2024
Date Received
September 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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  • K261067 — BEE PLIF Cage (April 30, 2026)
  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K253583 — LUX Expandable Lumbar Interbody System (February 23, 2026)
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FDA data resources