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FDA 510(k)

Cervical Interbody Fusion System

K-Number: K160324 · 2016-05-05

ApplicantEvolution Spine, LLC
Decision Date2016-05-05
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Interbody Fusion System is a medical device manufactured by Evolution Spine, LLC. It received FDA 510(k) clearance on 2016-05-05 under approval number K160324. 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 Cervical Interbody Fusion System?

Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2016-05-05. It is manufactured by Evolution Spine, LLC. The 510(k) number is K160324.

When was Cervical Interbody Fusion System approved by the FDA?

Cervical Interbody Fusion System received FDA 510(k) clearance on 2016-05-05, under approval number K160324.

What company makes Cervical Interbody Fusion System?

Cervical Interbody Fusion System is manufactured by Evolution Spine, LLC.

What is the FDA product code for Cervical Interbody Fusion System?

The FDA product code for 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 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 NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024) PMID: 28256243 Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration. Journal of biomechanics (2017)

Other Devices by Evolution Spine, LLC

K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) K173375Anterior Cervical Plate System K180755Vail ALIF Buttress Plate System K182478Whistler Modular 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.

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