ELEOS with NanoCept® Technology Limb Salvage System— 510(k) K253066
Substantially EquivalentOnkos Surgical, Inc.
FDA 510(k) clearance K253066 for ELEOS with NanoCept® Technology Limb Salvage System, Substantially Equivalent on 2026-06-08. Applicant: Onkos Surgical, Inc.. Device class: 2.
Summary
Onkos Surgical's ELEOS with NanoCept Technology Limb Salvage System is filed under QZZ, which the code name gives as limb and joint salvage devices with coating for bacteria reduction. The record doesn't describe the NanoCept technology or list components.
Class II, 21 CFR 888.3900. Orthopedic is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Onkos filed from Parsippany, New Jersey. The decision came 259 calendar days after receipt (September 22, 2025 to June 8, 2026).
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parsippany, NJ, US
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