510(k) clearance
ELEOS™ Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C)
- 510(k) number
- K263628
- Applicant
- Onkos Surgical, Inc.
- Decision date
- Oct 29, 2026
- Date received
- Sep 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- QZZ
- Device type
- Limb And Joint Salvage Device With Coating For Bacteria Reduction
- Device class
- Class II
- Regulation
- 21 CFR 888.3900
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Parsippany, NJ, US