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FDA 510(k)

Standalone ALIF Interbody Fusion System

K-Number: K221936 · 2022-10-17

ApplicantEminent Spine
Decision Date2022-10-17
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Standalone ALIF Interbody Fusion System is a medical device manufactured by Eminent Spine. It received FDA 510(k) clearance on 2022-10-17 under approval number K221936. 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 Standalone ALIF Interbody Fusion System?

Standalone ALIF Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2022-10-17. It is manufactured by Eminent Spine. The 510(k) number is K221936.

When was Standalone ALIF Interbody Fusion System approved by the FDA?

Standalone ALIF Interbody Fusion System received FDA 510(k) clearance on 2022-10-17, under approval number K221936.

What company makes Standalone ALIF Interbody Fusion System?

Standalone ALIF Interbody Fusion System is manufactured by Eminent Spine.

What is the FDA product code for Standalone ALIF Interbody Fusion System?

The FDA product code for Standalone ALIF Interbody Fusion System is OVD.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes 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 NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Eminent Spine

K212701Eminent Spine 3D Cervical Interbody Fusion System K242069Eminent Spine Scoliosis Deformity Pedicle Screw System K250894Eminent Spine Posterior SI System K241663Eminent Spine 3D Titanium Pedicle Screw System

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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