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FDA 510(k)

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System

K-Number: K230808 · 2023-04-21

ApplicantKyocera Medical Technologies, Inc.
Decision Date2023-04-21
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEEK 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 2023-04-21 under 510(k) number K230808. 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 PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System?

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K230808.

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

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System received FDA 510(k) clearance on 2023-04-21, under 510(k) number K230808.

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

The FDA product code for PEEK 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)RECRUITINGNCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITINGNCT06904898CONDUIT vs. PEEK CagesACTIVE_NOT_RECRUITINGNCT07777718Lumbar Fusion With Nanotube Versus Titanium CageNOT_YET_RECRUITINGNCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_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

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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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