E3D-A Interbody System— 510(k) K232432

Name: FDA 510(k) clearance K232432
Creator: U.S. Food and Drug Administration
Published: 2024-01-30

Substantially Equivalent

Evolution Spine

FDA 510(k) clearance K232432 for E3D-A Interbody System, Substantially Equivalent on 2024-01-30. Applicant: Evolution Spine. Device class: 2.

Clearance details

Applicant: Evolution Spine
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-08-11
Decision date: 2024-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

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K262025 — Innovasis AxTiHA® Stand-Alone ALIF System +2 more2026-09-11
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

More clearances from Evolution Spine

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K262094 — E3D-C Interbody System2026-07-22
K260038 — E3D-C Interbody System2026-02-04
K250167 — Evolution Spine Navigation Instruments2025-08-18
K241846 — E3D-C Interbody System2024-08-12
K240368 — E3D-A Interbody System2024-05-15

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.