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 1 of 16

Device	Model / Reference	Registries	Class	Status
Eleos™	2500L002E	FDA UDI	Class II	Active
Eleos™	KSP20100E	FDA UDI	Class II	Active
ELEOS Limb Salvage System	CS-15120-03M	FDA UDI	Class II	Active
ELEOS™ Limb Salvage System	RF-R003E-01M	FDA UDI	Class II	Active
Eleos™	001-03-10010	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	CS-65080-04M	FDA UDI	Class II	Active
Eleos™	K0056510E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	CS-65050-04M	FDA UDI	Class II	Active
Eleos™	K0051017E	FDA UDI	Class I	Active
Eleos™	K0002008E	FDA UDI	Class I	Active
Eleos™	25100008E	FDA UDI	Class I	Active
Eleos™	25101220E	FDA UDI	Class I	Active
Eleos™	K0001112E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	CS-65040-04M	FDA UDI	Class II	Active
ELEOS Limb Salvage System	FB-21152-03M	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	mktp/Std15	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	Smbsh01	FDA UDI	Class II	Active
Eleos™	25002200E	FDA UDI	Class II	Active
ELEOS Limb Salvage System With BioGrip	SB-170RT-03N	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	CS-65010-04M	FDA UDI	Class II	Active
ELEOS Limb Salvage System	CS-09100-03M	FDA UDI	Class II	Active
Jts Extendible Distal Femoral Implant	Smbpr02	FDA UDI	Class II	Active
Eleos™	K0002015E	FDA UDI	Class I	Active
Eleos™	25002203E	FDA UDI	Class II	Active
My3D® Personalized Pelvic Reconstruction	PN-32089-04N	FDA UDI	Class II	Active
Eleos™	001-03-10011	FDA UDI	Class I	Active
Eleos™	18410213E	FDA UDI	Class I	Active
Eleos™	K0053020E	FDA UDI	Class I	Active
Eleos™	K0051124E	FDA UDI	Class I	Active
Eleos™	25100111E	FDA UDI	Class I	Active
ELEOS Limb Salvage System With BioGrip	HB-3200R-03M	FDA UDI	Class II	Active
Eleos™	25100040E	FDA UDI	Class I	Active
Eleos Limb Salvage System With Nanocept Technology	AM-MS-060MF	FDA UDI	Class II	Active
Eleos™	BT-11152-03N	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	LS-50075-04M	FDA UDI	Class II	Active
Eleos™	25101212E	FDA UDI	Class I	Active
Eleos Limb Salvage System With Nanocept Technology	AM-MS-050MF	FDA UDI	Class II	Active
Eleos™	25100071E	FDA UDI	Class I	Active
Eleos™	18056007E	FDA UDI	Class I	Active
Eleos™	K0051116E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	PV-TRYLD-04T	FDA UDI	Class II	Active
Eleos™	K0053021E	FDA UDI	Class I	Active
Jts Extendible Distal Femoral Implant	tmktp/ExSm10	FDA UDI	Class II	Active
Eleos™	KSP13100E	FDA UDI	Class II	Active
Eleos™	001-03-00017	FDA UDI	Class I	Active
Eleos™	K0000901E	FDA UDI	Class I	Active
My3D® Personalized Pelvic Reconstruction	LS-50024-04M	FDA UDI	Class II	Active
Eleos™	002-03-00007	FDA UDI	Class I	Active
Eleos™	2500CC15E	FDA UDI	Class II	Active
Eleos™	25004013E	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