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FDA 510(k)

Juliet® Ti LL Lumbar Interbody Device

K-Number: K190877 · 2019-05-29

ApplicantSpineart
Decision Date2019-05-29
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Juliet® Ti LL Lumbar Interbody Device is the device name listed in this FDA 510(k) record. The listed applicant is Spineart. It received FDA 510(k) clearance on 2019-05-29 under 510(k) number K190877. 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 Juliet® Ti LL Lumbar Interbody Device?

Juliet® Ti LL Lumbar Interbody Device is a medical device that received FDA 510(k) clearance on 2019-05-29. The listed applicant is Spineart. The 510(k) number is K190877.

When did Juliet® Ti LL Lumbar Interbody Device receive FDA 510(k) clearance?

Juliet® Ti LL Lumbar Interbody Device received FDA 510(k) clearance on 2019-05-29, under 510(k) number K190877.

Who is the listed applicant for Juliet® Ti LL Lumbar Interbody Device?

The FDA 510(k) record lists Spineart as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Juliet® Ti LL Lumbar Interbody Device?

The FDA product code for Juliet® Ti LL Lumbar Interbody Device is OVD.

Other records listing Spineart 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.

K262639BAGUERA® C Cervical Disc Surgical InstrumentsK261205SPINEART Navigation Instrument SystemK253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemK254158SPINEART Navigation Instrument SystemK242933SPINEART Navigation Instrument SystemK242890SPINEART Navigation Instrument 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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