Is this your brand? Sign in to claim ownership.

ONKOS SURGICAL, INC.

Last updated September 17, 2026

Information

Country: US
Address: 77 E HALSEY RD, Parsippany, NJ, 07054
Website: onkossurgical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(844)767-2766
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3013450937
DUNS Number: 080254074

Catalogue (800)

Page 6 of 16

Device	Model / Reference	Registries	Class	Status
Eleos™	K0050511E	FDA UDI	Class I	Active
Eleos™	25102301E	FDA UDI	Class I	Active
Eleos™	26012805E	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	imtrrhm/ExSm	FDA UDI	Class II	Active
Eleos™	001-03-00010	FDA UDI	Class I	Active
Eleos™	25100050E	FDA UDI	Class I	Active
Eleos™	RT-11500-03N	FDA UDI	Class I	Active
Eleos™	K0053039E	FDA UDI	Class I	Active
Eleos™	001-03-10005	FDA UDI	Class I	Active
ELEOS™ Limb Salvage System	CB-13200-03M	FDA UDI	Class II	Active
Eleos™	18811215E	FDA UDI	Class I	Active
ELEOS Limb Salvage System	FB-17152-03M	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	HY-RULDF-03N	FDA UDI	Class I	Active
Eleos™	25100015E	FDA UDI	Class I	Active
Eleos™	BT-19152-03N	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	CS-65035-04M	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	tmktp/Std5	FDA UDI	Class II	Active
Eleos™	K0051005E	FDA UDI	Class I	Active
Eleos™	K0050513E	FDA UDI	Class I	Active
Eleos™	002-03-00021	FDA UDI	Class I	Active
Eleos™	001-03-00007	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	LS-50080-04M	FDA UDI	Class II	Active
Eleos™	20040113E	FDA UDI	Class I	Active
ELEOS Limb Salvage System	CS-13120-03M	FDA UDI	Class II	Active
Eleos™	K0001101E	FDA UDI	Class I	Active
Eleos™	18056020E	FDA UDI	Class I	Active
Eleos™	K0050519E	FDA UDI	Class I	Active
ELEOS Limb Salvage System With BioGrip	SB-GAUGE-03N	FDA UDI	Class I	Active
Eleos™	25107209E	FDA UDI	Class I	Active
Eleos™	25107614E	FDA UDI	Class I	Active
Eleos™	BT-17152-03N	FDA UDI	Class I	Active
Eleos™	001-03-10007	FDA UDI	Class I	Active
Eleos™	KTAGW515E	FDA UDI	Class II	Active
Eleos™	K0053013E	FDA UDI	Class I	Active
Eleos™	25008015E	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	CS-65070-04M	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	PL-00015-03N	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	CS-65045-04M	FDA UDI	Class II	Active
Eleos™	26000026E	FDA UDI	Class III	Active
Eleos™	25002112E	FDA UDI	Class II	Active
Eleos™	KSC01265E	FDA UDI	Class II	Active
Eleos™	KSC01500E	FDA UDI	Class II	Active
ELEOS Limb Salvage System	FB-13152-03M	FDA UDI	Class II	Active
Eleos™	001-03-00029	FDA UDI	Class I	Active
Eleos™	2500L004E	FDA UDI	Class II	Active
Eleos™	18056054E	FDA UDI	Class I	Active
ELEOS Limb Salvage System With BioGrip	TW-T2514-01N	FDA UDI	Class I	Active
ELEOS Limb Salvage System	FB-14152-03M	FDA UDI	Class II	Active
Eleos™	KSP17100E	FDA UDI	Class II	Active
Eleos™	KSP14100E	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (16)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 11, 2025	Z-2424-2025	—	open, classified	Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Jul 11, 2025	Z-2423-2025	—	open, classified	Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Jul 11, 2025	Z-2425-2025	—	open, classified	Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
May 20, 2025	Z-2042-2025	—	open, classified	Required inspections were not performed on finished product prior to release and distribution.
Sep 22, 2024	Z-1857-2025	—	open, classified	Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Dec 22, 2023	Z-1818-2025	—	open, classified	Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
Dec 22, 2023	Z-1817-2025	—	open, classified	Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
Sep 1, 2023	Z-1882-2025	—	open, classified	Potential for breach of Tyvek seals.
Sep 1, 2023	Z-1880-2025	—	open, classified	Potential for breach of Tyvek seals.
Sep 1, 2023	Z-1884-2025	—	open, classified	Potential for breach of Tyvek seals.
Sep 1, 2023	Z-1883-2025	—	open, classified	Potential for breach of Tyvek seals.
Sep 1, 2023	Z-1881-2025	—	open, classified	Potential for breach of Tyvek seals.
Sep 1, 2023	Z-1879-2025	—	open, classified	Potential for breach of Tyvek seals.
May 23, 2017	Z-2646-2017	—	terminated	The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
May 23, 2017	Z-2648-2017	—	terminated	The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
May 23, 2017	Z-2647-2017	—	terminated	The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm