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Onkos Surgical, Inc.

13 FDA 510(k) clearances · Recalling firm

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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
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of recall (Z-2042-2025)Onkos Surgical, Inc.2025-06-27
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-1010 recall (Z-1879-2025)Onkos Surgical, Inc.2025-05-29
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, recall (Z-1880-2025)Onkos Surgical, Inc.2025-05-29
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12 recall (Z-1881-2025)Onkos Surgical, Inc.2025-05-29
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152- recall (Z-1882-2025)Onkos Surgical, Inc.2025-05-29
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
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsecti recall (Z-1884-2025)Onkos Surgical, Inc.2025-05-29
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage recall (Z-1857-2025)Onkos Surgical, Inc.2025-05-28
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

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Every clearance here is in the API, with alerts when new ones post.