ADI TiDAL Osteotomy Wedge— 510(k) K191047

Name: FDA 510(k) clearance K191047
Creator: U.S. Food and Drug Administration
Published: 2019-11-05

Substantially Equivalent

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

FDA 510(k) clearance K191047 for ADI TiDAL Osteotomy Wedge, Substantially Equivalent on 2019-11-05. 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 PLF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2019-04-19
Decision date: 2019-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLF

view all

K252733 — ATLAS Expandable Osteotomy Wedge System2026-02-19
K252254 — Osteotomy Wedge System2025-10-17
K251791 — Auxano® Wedge Fixation System2025-09-25
K240461 — OsteoSinter® EVANS and COTTON wedges and related accessories2024-12-06
K243231 — Trigon PEEK HA Wedges2024-11-08

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

view all

K191812 — ADI Cervical Interbody Fusion Device2019-10-24

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