Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System— 510(k) K232530

Name: FDA 510(k) clearance K232530
Creator: U.S. Food and Drug Administration
Published: 2023-09-18

Substantially Equivalent

Nexus Spine, LLC

FDA 510(k) clearance K232530 for Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System, Substantially Equivalent on 2023-09-18. Applicant: Nexus Spine, LLC. Device class: 2.

Clearance details

Applicant: Nexus Spine, LLC
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-08-21
Decision date: 2023-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

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

More clearances from Nexus Spine, LLC

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K243934 — Stable-L Lumbar Interbody System2025-04-30
K241467 — Stable-C Interbody System2024-07-17
K233375 — Tranquil-L Interbody System2024-03-20
K240416 — Tranquil-C Interbody System2024-03-12
K233234 — PressON Spinal Fixation System2023-10-26

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.