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FDA 510(k)

Tesera-k SC System

K-Number: K242928 · 2025-04-10

ApplicantKyocera Medical Technologies, Inc.
Decision Date2025-04-10
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tesera-k SC 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 2025-04-10 under 510(k) number K242928. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tesera-k SC System?

Tesera-k SC System is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K242928.

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

Tesera-k SC System received FDA 510(k) clearance on 2025-04-10, under 510(k) number K242928.

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

The FDA product code for Tesera-k SC System is OVE.

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 SystemK242045Initia T3 Acetabular Hemispherical Shell SystemK242771Tesera-k PL System and Tesera-k XL SystemK243295Initia Knee SystemK243015Skyway Anterior Cervical Plate SystemK232114TRIBRID® Unicompartmental Knee System

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Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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