FDA 510(k)

Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System

K-Number: K261353 · 2026-07-15

ApplicantKyocera Medical Technologies, Inc.

Decision Date2026-07-15

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor 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 2026-07-15 under 510(k) number K261353. 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 Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System?

Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System is a medical device that received FDA 510(k) clearance on 2026-07-15. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K261353.

When did Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System receive FDA 510(k) clearance?

Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System received FDA 510(k) clearance on 2026-07-15, under 510(k) number K261353.

Who is the listed applicant for Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor 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 Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System?

The FDA product code for Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System is OVD.

Related Clinical Trials

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.

NCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITING NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITING NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITING NCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING

Other records listing Kyocera Medical Technologies, Inc. as applicant

K242928Tesera-k SC System K242045Initia T3 Acetabular Hemispherical Shell System K242771Tesera-k PL System and Tesera-k XL System K243295Initia Knee System K243015Skyway Anterior Cervical Plate System K232114TRIBRID® Unicompartmental Knee System

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Related Devices (Code: OVD)

K260810Anteralign LS coverplateTyber Medical, LLC K254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec 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.