A-Link Z— 510(k) K201671

Name: FDA 510(k) clearance K201671
Creator: U.S. Food and Drug Administration
Published: 2021-05-04

Substantially Equivalent

Acuity Surgical Devices, LLC

FDA 510(k) clearance K201671 for A-Link Z, Substantially Equivalent on 2021-05-04. Applicant: Acuity Surgical Devices, LLC. Device class: 2.

Clearance details

Applicant: Acuity Surgical Devices, LLC
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2020-06-19
Decision date: 2021-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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K241413 — sagAlign Lumbar Cage System (Various PNs)2024-07-17
K230639 — Align Cervical Interbody Fusion System2023-12-01

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.