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FDA 510(k)

MectaLIF Transforaminal TiPEEK

K-Number: K200551 · 2021-02-12

ApplicantMedacta Inernational SA
Decision Date2021-02-12
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaLIF Transforaminal TiPEEK is the device name listed in this FDA 510(k) record. The listed applicant is Medacta Inernational SA. It received FDA 510(k) clearance on 2021-02-12 under 510(k) number K200551. 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 MectaLIF Transforaminal TiPEEK?

MectaLIF Transforaminal TiPEEK is a medical device that received FDA 510(k) clearance on 2021-02-12. The listed applicant is Medacta Inernational SA. The 510(k) number is K200551.

When did MectaLIF Transforaminal TiPEEK receive FDA 510(k) clearance?

MectaLIF Transforaminal TiPEEK received FDA 510(k) clearance on 2021-02-12, under 510(k) number K200551.

Who is the listed applicant for MectaLIF Transforaminal TiPEEK?

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

What is the FDA product code for MectaLIF Transforaminal TiPEEK?

The FDA product code for MectaLIF Transforaminal TiPEEK is MAX.

Other records listing Medacta Inernational SA 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.

K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesK193175Lateralized GlenosphereK193559NextAR TKA Platform

Related Devices (Code: MAX)

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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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.

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