Atlas FDA

ELEOS™ Limb Salvage System

FDA 510(k) clearance K203588 · decided 2021-02-05

Clearance details

K-number
K203588
Device name
ELEOS™ Limb Salvage System
Applicant
Onkos Surgical
Decision
Substantially Equivalent
Date received
2020-12-08
Decision date
2021-02-05
Days to decision
59 days
Clearance type
Traditional
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Parsippany, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem i recall (Z-2423-2025)Onkos Surgical, Inc.2025-08-25
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED S recall (Z-2424-2025)Onkos Surgical, Inc.2025-08-25
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Can recall (Z-2425-2025)Onkos Surgical, Inc.2025-08-25