ELEOS™ Limb Salvage System CB-17200-03M

GUDID B278CB1720003M0

ELEOS Segmental Stem, Cemented, 17mm x 200mm, Bowed, Fluted, 36mm Collar

ONKOS SURGICAL, INC.

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• Primary Device ID: B278CB1720003M0
• NIH Device Record Key: 3d252506-45af-42ad-aeaf-821175e69266
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELEOS™ Limb Salvage System
• Version Model Number: CB-17200-03M
• Catalog Number: CB-17200-03M
• Company DUNS: 080254074
• Company Name: ONKOS SURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B278CB1720003M0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161520

FDA Product Code

• KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[B278CB1720003M0]

Radiation Sterilization

[B278CB1720003M0]

Radiation Sterilization

[B278CB1720003M0]

Radiation Sterilization

[B278CB1720003M0]

Radiation Sterilization

[B278CB1720003M0]

Radiation Sterilization

[B278CB1720003M0]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-14
• Device Publish Date: 2022-06-06

On-Brand Devices [ELEOS™ Limb Salvage System]

• B278TB2205E01M0: ELEOS™ TIBIAL BASEPLATE, SIZE 5 80MM M/L
• B278TB2204E01M0: ELEOS™ TIBIAL BASEPLATE, SIZE 4 75MM M/L
• B278TB2203E01M0: ELEOS™ TIBIAL BASEPLATE, SIZE 3 70MM M/L
• B278TB2202E01M0: ELEOS™ TIBIAL BASEPLATE, SIZE 2 65MM M/L
• B278TB2201E01M0: ELEOS™ TIBIAL BASEPLATE, SIZE 1 60MM M/L
• B27800103000210: ELEOS™ INSTRUMENTATION TRAY, 21
• B27800103000220: ELEOS™ INSTRUMENTATION TRAY, 22
• B278RFR004E01M0: ELEOS™ Resurfacing Femur, Size 4, Right
• B278RFR003E01M0: ELEOS™ Resurfacing Femur, Size 3, Right
• B278RFR002E01M0: ELEOS™ Resurfacing Femur, Size 2, Right
• B278RFL004E01M0: ELEOS™ Resurfacing Femur, Size 4, Left
• B278RFL003E01M0: ELEOS™ Resurfacing Femur, Size 3, Left
• B278RFL002E01M0: ELEOS™ Resurfacing Femur, Size 2, Left
• B278TBTSCRW01N0: ELEOS™ Tibial Baseplate Tapered Screw
• B278RFTSCRW01N0: ELEOS™ Resurfacing Femur Tapered Screw
• B278THSMWOS01M0: ELEOS™ TIBIAL HINGE W/OUT ROTATIONAL STOP ONE SIZE
• B278TBTSCRW01M0: ELEOS™ Tibial Baseplate Tapered Screw
• B278RFTSCRW01M0: ELEOS™ Resurfacing Femur Tapered Screw
• B278CB1720003M0: ELEOS Segmental Stem, Cemented, 17mm x 200mm, Bowed, Fluted, 36mm Collar
• B278CB1520003M0: ELEOS Segmental Stem, Cemented, 15mm x 200mm, Bowed, Fluted, 32mm Collar
• B278CB1320003M0: ELEOS Segmental Stem, Cemented, 13mm x 200mm, Bowed, Fluted, 28mm Collar
• B278CB1125503M0: ELEOS Segmental Stem, Cemented, 11mm x 255mm, Bowed, Fluted, 32mm Collar