ELEOS Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C)— 510(k) K263628

Name: FDA 510(k) clearance K263628
Creator: U.S. Food and Drug Administration
Published: 2026-10-29

Substantially Equivalent

Onkos Surgical, Inc.

FDA 510(k) clearance K263628 for ELEOS Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C), Substantially Equivalent on 2026-10-29. Applicant: Onkos Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Onkos Surgical, Inc.
Product code: Product code QZZ
Device class: Class 2
Regulation: 21 CFR 888.3900
Advisory panel: Orthopedic
Date received: 2026-09-30
Decision date: 2026-10-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QZZ

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K253066 — ELEOS with NanoCept® Technology Limb Salvage System2026-06-08
K252920 — ELEOS Limb Salvage System with NanoCept® Technology2025-10-15
DEN210058 — ELEOSx Limb Salvage System2024-04-05

More clearances from Onkos Surgical, Inc.

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K223348 — My3D® Personalized Pelvic Reconstruction2023-01-30
K180130 — ELEOS Bipolar Acetabular System2018-02-23
K161520 — ELEOS Limb Salvage System2016-10-28

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