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FDA 510(k)

ADI Cervical Interbody Fusion Device

K-Number: K191812 · 2019-10-24

ApplicantAdditive Device, Inc. (Adi) D/B/A Restor3D
Decision Date2019-10-24
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ADI Cervical Interbody Fusion Device is a medical device manufactured by Additive Device, Inc. (Adi) D/B/A Restor3D. It received FDA 510(k) clearance on 2019-10-24 under approval number K191812. 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 ADI Cervical Interbody Fusion Device?

ADI Cervical Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2019-10-24. It is manufactured by Additive Device, Inc. (Adi) D/B/A Restor3D. The 510(k) number is K191812.

When was ADI Cervical Interbody Fusion Device approved by the FDA?

ADI Cervical Interbody Fusion Device received FDA 510(k) clearance on 2019-10-24, under approval number K191812.

What company makes ADI Cervical Interbody Fusion Device?

ADI Cervical Interbody Fusion Device is manufactured by Additive Device, Inc. (Adi) D/B/A Restor3D.

What is the FDA product code for ADI Cervical Interbody Fusion Device?

The FDA product code for ADI Cervical Interbody Fusion Device is ODP.

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 NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer 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: 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 Additive Device, Inc. (Adi) D/B/A Restor3D

K191047ADI TiDAL Osteotomy Wedge

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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