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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 the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2022-01-07 under 510(k) 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. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K212980.

When did Tesera-k ALIF System receive FDA 510(k) clearance?

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

Who is the listed applicant for Tesera-k ALIF System?

The FDA 510(k) record lists Kyocera Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Kyocera Medical Technologies, Inc. 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.

K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemK242928Tesera-k SC SystemK242045Initia T3 Acetabular Hemispherical Shell SystemK242771Tesera-k PL System and Tesera-k XL SystemK243295Initia Knee SystemK243015Skyway Anterior Cervical Plate System

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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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