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FDA 510(k)

Curiteva Cervical Interbody Fusion System

K-Number: K181261 · 2018-07-09

ApplicantCuriteva, LLC
Decision Date2018-07-09
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Curiteva Cervical Interbody Fusion System is a medical device manufactured by Curiteva, LLC. It received FDA 510(k) clearance on 2018-07-09 under approval number K181261. 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 Curiteva Cervical Interbody Fusion System?

Curiteva Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2018-07-09. It is manufactured by Curiteva, LLC. The 510(k) number is K181261.

When was Curiteva Cervical Interbody Fusion System approved by the FDA?

Curiteva Cervical Interbody Fusion System received FDA 510(k) clearance on 2018-07-09, under approval number K181261.

What company makes Curiteva Cervical Interbody Fusion System?

Curiteva Cervical Interbody Fusion System is manufactured by Curiteva, LLC.

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

The FDA product code for Curiteva 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 Curiteva, LLC

K181589Curiteva Lumbar Interbody Fusion System K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) K181562Curiteva Anterior Cervical Plate 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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