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FDA 510(k)

MectaLIF Anterior Extension

K-Number: K221545 · 2022-10-24

ApplicantMedacta International S.A.
Decision Date2022-10-24
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaLIF Anterior Extension is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2022-10-24 under 510(k) number K221545. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MectaLIF Anterior Extension?

MectaLIF Anterior Extension is a medical device that received FDA 510(k) clearance on 2022-10-24. The listed applicant is Medacta International S.A.. The 510(k) number is K221545.

When did MectaLIF Anterior Extension receive FDA 510(k) clearance?

MectaLIF Anterior Extension received FDA 510(k) clearance on 2022-10-24, under 510(k) number K221545.

Who is the listed applicant for MectaLIF Anterior Extension?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MectaLIF Anterior Extension?

The FDA product code for MectaLIF Anterior Extension is OVD.

Other records listing Medacta International S.A. as applicant

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.

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Related Devices (Code: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.

Official Source

View on FDA Database →

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

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