FDA 510(k)

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

K-Nummer: K232996 · 2024-09-06

AntragstellerShanghai Iatrical-Ti Technologies CO , Ltd.

Entscheidungsdatum2024-09-06

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: MAX)

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