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FDA 510(k)

Tesera-k ALIF System

K-Number: K212980 · 2022-01-07

ApplicantKyocera Medical Technologies, Inc.
Decision Date2022-01-07
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tesera-k ALIF System is a medical device manufactured by Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2022-01-07 under approval number K212980. 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 Tesera-k ALIF System?

Tesera-k ALIF System is a medical device that received FDA 510(k) clearance on 2022-01-07. It is manufactured by Kyocera Medical Technologies, Inc.. The 510(k) number is K212980.

When was Tesera-k ALIF System approved by the FDA?

Tesera-k ALIF System received FDA 510(k) clearance on 2022-01-07, under approval number K212980.

What company makes Tesera-k ALIF System?

Tesera-k ALIF System is manufactured by Kyocera Medical Technologies, Inc..

What is the FDA product code for Tesera-k ALIF System?

The FDA product code for Tesera-k ALIF System is OVD.

Other Devices by Kyocera Medical Technologies, Inc.

K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K200709Kyocera Bipolar Hip System K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System K212070KMTI S141 Lumbar Interbody Fusion System K203472KMTI Hip Replacement System

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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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