FBC 921 (ALIF)— 510(k) K180695

Name: FDA 510(k) clearance K180695
Creator: U.S. Food and Drug Administration
Published: 2018-07-12

Substantially Equivalent

Fbc Device Aps

FDA 510(k) clearance K180695 for FBC 921 (ALIF), Substantially Equivalent on 2018-07-12. Applicant: Fbc Device Aps. Device class: 2.

Clearance details

Applicant: Fbc Device Aps
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2018-03-16
Decision date: 2018-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Risskov, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

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K261408 — SABER-XA System2026-08-03
K261809 — Interwedge® Standalone Lateral2026-07-31
K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K260810 — Anteralign LS coverplate2026-06-10
K254202 — MectaLIF 3D Metal Anterior2026-05-05

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.