FDA.reportPublic FDA data

ELEOS™

Primary DI
B278RT1550003N0
Brand
ELEOS™
Company
ONKOS SURGICAL, INC.
Model
RT-15500-03N
Catalog number
RT-15500-03N
Device description
Reamer Trial 15.5x120MM
Published
2018-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161520000ELEOS Limb Salvage SystemOnkos Surgical, Inc.2016-10-28KRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B278RT1550003N0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(844)767-2766customerservice@onkossurgical.
+1(844)767-2766customerservice@onkossurgical.com

Regulatory Flags#

DUNS number
080254074
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B278AM25002200C0ELEOS™ Limb Salvage System with NanoCept® TechnologyAM-25002200-CAM-25002200-C2026-06-09
B278IMPBIMPEXSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/ExSmIMPBIMP-EXSM2024-07-22
B278IMPBIMPSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/SmIMPBIMP-SM2024-07-22
B278IMGENIMP0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimgenimpIMGENIMP2024-07-19
B278IMPBIMPSTD0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/StdIMPBIMP-STD2024-07-19
B278HDSP03604N0My3D® Personalized Pelvic Reconstruction DG-SP036-04NDG-SP036-04N2023-02-22
B278IMCIRPR0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimcirprIMCIRPR2024-07-19
B278HC1112003M0ELEOS Limb Salvage System With BioGripHC-11120-03M HC-11120-03M 2021-06-30
B278HC1312003M0ELEOS Limb Salvage System With BioGripHC-13120-03M HC-13120-03M 2021-06-30
B278HC1512003M0ELEOS Limb Salvage System With BioGripHC-15120-03M HC-15120-03M 2021-06-30
B278HC1712003M0ELEOS Limb Salvage System With BioGripHC-17120-03M HC-17120-03M 2021-06-30
B278DV3500004N0My3D® Personalized Pelvic ReconstructionDV-35000-04N2025-09-22
B278DVMOD3504N0My3D® Personalized Pelvic ReconstructionDV-MOD35-04N2025-09-22
B278DVRDG3504N0My3D® Personalized Pelvic ReconstructionDV-RGD35-04N2025-09-22
B278PINS0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTibnpinPINS2024-07-22
B278LS5001804M0My3D® Personalized Pelvic Reconstruction LS-50018-04M2024-03-11
B278LS5004604M0My3D® Personalized Pelvic Reconstruction LS-50046-04M2024-03-11
B278LS5002004M0My3D® Personalized Pelvic Reconstruction LS-50020-04M2024-03-08
B278LS5002204M0My3D® Personalized Pelvic Reconstruction LS-50022-04M2024-03-08
B278LS5002404M0My3D® Personalized Pelvic Reconstruction LS-50024-04M2024-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286853163TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286853170TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286853187TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286855587TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286855921TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859929TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859943TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859967TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859974TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859981TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859998TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860000TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860123Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860130Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860222Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860444Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860468Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860482Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860505Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860529Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860543Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860567Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860581Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860604Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00889024701281Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701298Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701304Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701311Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701328Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701335Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10