Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Eminent Spine 3D Cervical Interbody Fusion System

K-Number: K212701 · 2023-02-06

ApplicantEminent Spine
Decision Date2023-02-06
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Eminent Spine 3D Cervical Interbody Fusion System is a medical device manufactured by Eminent Spine. It received FDA 510(k) clearance on 2023-02-06 under approval number K212701. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eminent Spine 3D Cervical Interbody Fusion System?

Eminent Spine 3D Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-02-06. It is manufactured by Eminent Spine. The 510(k) number is K212701.

When was Eminent Spine 3D Cervical Interbody Fusion System approved by the FDA?

Eminent Spine 3D Cervical Interbody Fusion System received FDA 510(k) clearance on 2023-02-06, under approval number K212701.

What company makes Eminent Spine 3D Cervical Interbody Fusion System?

Eminent Spine 3D Cervical Interbody Fusion System is manufactured by Eminent Spine.

What is the FDA product code for Eminent Spine 3D Cervical Interbody Fusion System?

The FDA product code for Eminent Spine 3D Cervical Interbody Fusion System is ODP.

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 NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_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 Eminent Spine

K221936Standalone ALIF 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: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.

↑