Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System

K-Number: K193320 · 2020-02-04

ApplicantKyocera Medical Technologies, Inc.
Decision Date2020-02-04
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KMTI Tesera SA Anterior Lumbar Interbody Fusion (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 2020-02-04 under 510(k) number K193320. 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 KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System?

KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System is a medical device that received FDA 510(k) clearance on 2020-02-04. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K193320.

When did KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System receive FDA 510(k) clearance?

KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System received FDA 510(k) clearance on 2020-02-04, under 510(k) number K193320.

Who is the listed applicant for KMTI Tesera SA Anterior Lumbar Interbody Fusion (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 KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System?

The FDA product code for KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) 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)RECRUITINGNCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITINGNCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITINGNCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING

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

View all 16 devices →

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.

↑