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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 a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2019-05-29 under approval 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. It is manufactured by Spineart. The 510(k) number is K190877.

When was Juliet® Ti LL Lumbar Interbody Device approved by the FDA?

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

What company makes Juliet® Ti LL Lumbar Interbody Device?

Juliet® Ti LL Lumbar Interbody Device is manufactured by Spineart.

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Spineart

K161888JULIET® LL Lateral Lumbar Cage K153621Juliet® Ti K153042TRYPTIK2C-plate Anterior Cervical Plate System K153386Perla Posterior Cervico-Thoracic Fixation system K151104OTELO LL K172065SCARLET AC-T

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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