ADI Cervical Interbody Fusion Device— 510(k) K191812

Name: FDA 510(k) clearance K191812
Creator: U.S. Food and Drug Administration
Published: 2019-10-24

Substantially Equivalent

Additive Device, Inc. (Adi) D/B/A Restor3D

FDA 510(k) clearance K191812 for ADI Cervical Interbody Fusion Device, Substantially Equivalent on 2019-10-24. Applicant: Additive Device, Inc. (Adi) D/B/A Restor3D. Device class: 2.

Clearance details

Applicant: Additive Device, Inc. (Adi) D/B/A Restor3D
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2019-07-05
Decision date: 2019-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

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K191047 — ADI TiDAL Osteotomy Wedge2019-11-05

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.