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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 the device name listed in this FDA 510(k) record. The listed applicant is Additive Device, Inc. (Adi) D/B/A Restor3D. It received FDA 510(k) clearance on 2019-10-24 under 510(k) 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. The listed applicant is Additive Device, Inc. (Adi) D/B/A Restor3D. The 510(k) number is K191812.

When did ADI Cervical Interbody Fusion Device receive FDA 510(k) clearance?

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

Who is the listed applicant for ADI Cervical Interbody Fusion Device?

The FDA 510(k) record lists Additive Device, Inc. (Adi) D/B/A Restor3D as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITING

Other records listing Additive Device, Inc. (Adi) D/B/A Restor3D as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191047ADI TiDAL Osteotomy Wedge

Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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