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FDA 510(k)

Avenue® T TLIF Cage

K-Number: K161173 · 2016-09-28

ApplicantLdr Spine USA, Inc.
Decision Date2016-09-28
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Avenue® T TLIF Cage is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA, Inc.. It received FDA 510(k) clearance on 2016-09-28 under 510(k) number K161173. 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 Avenue® T TLIF Cage?

Avenue® T TLIF Cage is a medical device that received FDA 510(k) clearance on 2016-09-28. The listed applicant is Ldr Spine USA, Inc.. The 510(k) number is K161173.

When did Avenue® T TLIF Cage receive FDA 510(k) clearance?

Avenue® T TLIF Cage received FDA 510(k) clearance on 2016-09-28, under 510(k) number K161173.

Who is the listed applicant for Avenue® T TLIF Cage?

The FDA 510(k) record lists Ldr Spine USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avenue® T TLIF Cage?

The FDA product code for Avenue® T TLIF Cage is OVD.

Other records listing Ldr Spine USA, 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.

K162133VerteFIT Corpectomy Cage SystemK161798FacetBRIDGE® SystemK153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemK152137FacetBRIDGE System

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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