FDA 510(k)

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)

K-Number: K232996 · 2024-09-06

ApplicantShanghai Iatrical-Ti Technologies CO , Ltd.

Decision Date2024-09-06

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Iatrical-Ti Technologies CO , Ltd.. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K232996. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)?

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Shanghai Iatrical-Ti Technologies CO , Ltd.. The 510(k) number is K232996.

When did Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) receive FDA 510(k) clearance?

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) received FDA 510(k) clearance on 2024-09-06, under 510(k) number K232996.

Who is the listed applicant for Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)?

The FDA 510(k) record lists Shanghai Iatrical-Ti Technologies CO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)?

The FDA product code for Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) is MAX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITING NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING NCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITING NCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT06904898CONDUIT vs. PEEK CagesACTIVE_NOT_RECRUITING

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.