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FDA 510(k)

MectaLIF Anterior Stand-Alone

K-Number: K160605 · 2016-07-21

ApplicantMedacta International
Decision Date2016-07-21
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaLIF Anterior Stand-Alone is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K160605. 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 Stand-Alone?

MectaLIF Anterior Stand-Alone is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Medacta International. The 510(k) number is K160605.

When did MectaLIF Anterior Stand-Alone receive FDA 510(k) clearance?

MectaLIF Anterior Stand-Alone received FDA 510(k) clearance on 2016-07-21, under 510(k) number K160605.

Who is the listed applicant for MectaLIF Anterior Stand-Alone?

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

What is the FDA product code for MectaLIF Anterior Stand-Alone?

The FDA product code for MectaLIF Anterior Stand-Alone is OVD.

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Other records listing Medacta International as applicant

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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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