Atlas FDA

ELEOS Limb Salvage System with BioGrip

FDA 510(k) clearance K203815 · decided 2021-06-09

Clearance details

K-number
K203815
Device name
ELEOS Limb Salvage System with BioGrip
Applicant
Onkos Surgical
Decision
Substantially Equivalent
Date received
2020-12-29
Decision date
2021-06-09
Days to decision
162 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
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100- recall (Z-1883-2025)Onkos Surgical, Inc.2025-05-29
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component o recall (Z-1817-2025)Onkos Surgical, Inc.2025-05-23
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component o recall (Z-1818-2025)Onkos Surgical, Inc.2025-05-23