ELEOS™ SPSETB11E

GUDID B278SPSETB11E0

TRIAL SEGMENTAL STEM 11MM X 152MM

ONKOS SURGICAL, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: B278SPSETB11E0
• NIH Device Record Key: a469cc1b-12a0-4243-a1c3-d63d67925d14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELEOS™
• Version Model Number: SPSETB11E
• Catalog Number: SPSETB11E
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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.
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B278SPSETB11E0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161520

FDA Product Code

• HWT: TEMPLATE

Sterilization

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

[B278SPSETB11E0]

Moist Heat or Steam Sterilization

[B278SPSETB11E0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-06

On-Brand Devices [ELEOS™]

• B278SPSETB17E0: TRIAL SEGMENTAL STEM 17MM X 152MM
• B278SPSETB15E0: TRIAL SEGMENTAL STEM 15MM X 152MM
• B278SPSETB13E0: TRIAL SEGMENTAL STEM 13MM X 152MM
• B278SPSETB11E0: TRIAL SEGMENTAL STEM 11MM X 152MM
• B278SPSEB017E0: ELEOS™ SEGMENTAL STEM, CEMENTED BOWED, FLUTED, 25MM COLLAR 17MM X 152MM
• B278SPSEB015E0: ELEOS™ SEGMENTAL STEM, CEMENTED BOWED, FLUTED, 25MM COLLAR 15MM X 152MM
• B278SPSEB013E0: ELEOS™ SEGMENTAL STEM, CEMENTED BOWED, FLUTED, 25MM COLLAR 13MM X 152MM
• B278SPSEB011E0: ELEOS™ SEGMENTAL STEM, CEMENTED BOWED, FLUTED, 25MM COLLAR 11MM X 152MM
• B278SPSE0005E0: ELEOS™ SEGMENTAL STEM, CANAL FILLING STRAIGHT, SLOTTED, SPLINED, 2/3 PLASMA, 25MM COLLAR 18M
• B278SPSE0004E0: ELEOS™ SEGMENTAL STEM, CANAL FILLING STRAIGHT, SLOTTED, SPLINED, 2/3 PLASMA, 25MM COLLAR 16M
• B278SPSE0003E0: ELEOS™ SEGMENTAL STEM, CANAL FILLING STRAIGHT, SLOTTED, SPLINED, 2/3 PLASMA, 25MM COLLAR 14M
• B278SPSE0002E0: ELEOS™ SEGMENTAL STEM, CANAL FILLING STRAIGHT, SLOTTED, SPLINED, 2/3 PLASMA, 25MM COLLAR 12M
• B278SI7501E03N0: Stem Impactor
• B278RTADAPT03N0: Reamer Trial Power Adaptor
• B278RT2100003N0: Reamer Trial 21x120MM
• B278RT2050003N0: Reamer Trial 20.5x120MM
• B278RT2000003N0: Reamer Trial 20x120MM
• B278RT1950003N0: Reamer Trial 19.5x120MM
• B278RT1900003N0: Reamer Trial 19x120MM
• B278RT1850003N0: Reamer Trial 18.5x120MM
• B278RT1800003N0: Reamer Trial 18x120MM
• B278RT1750003N0: Reamer Trial 17.5x120MM
• B278RT1700003N0: Reamer Trial 17x120MM
• B278RT1650003N0: Reamer Trial 16.5x120MM
• B278RT1600003N0: Reamer Trial 16x120MM
• B278RT1550003N0: Reamer Trial 15.5x120MM
• B278RT1500003N0: Reamer Trial 15x120MM
• B278RT1450003N0: Reamer Trial 14.5x120MM
• B278RT1400003N0: Reamer Trial 14x120MM
• B278RT1350003N0: Reamer Trial 13.5x120MM
• B278RT1300003N0: Reamer Trial 13x120MM
• B278RT1250003N0: Reamer Trial 12.5x120MM
• B278RT1200003N0: Reamer Trial 12x120MM
• B278RT1150003N0: Reamer Trial 11.5x120MM
• B278RT1100003N0: Reamer Trial 11x120MM
• B278RT1050003N0: Reamer Trial 10.5x120MM
• B278RT1000003N0: Reamer Trial 10x100MM
• B278RT0900003N0: Reamer Trial 9x100MM
• B278RGRINGS03N0: Ring Gages
• B278KTAGW515E0: TIBIAL AUGMENT 5 / 4+ X 15° NONPOROUS 5 / 4+ X 15°
• B278KTAGW415E0: TIBIAL AUGMENT 4 / 3+ X 15° NONPOROUS 4 / 3+ X 15°
• B278KTAGW315E0: TIBIAL AUGMENT 3 / 2+ X 15° NONPOROUS 3 / 2+ X 15°
• B278KTAGW215E0: TIBIAL AUGMENT 2 / 1+ X 15° NONPOROUS 2 / 1+ X 15°
• B278KTAGW115E0: TIBIAL AUGMENT 1 X 15° NONPOROUS 1 X 15°
• B278KTAGB515E0: TIBIAL AUGMENT, NONPOROUS, SIZE 5 X 15MM
• B278KTAGB510E0: TIBIAL AUGMENT, NONPOROUS, SIZE 5 X 10MM
• B278KTAGB505E0: TIBIAL AUGMENT, NONPOROUS, SIZE 5 X 5MM
• B278KTAGB415E0: TIBIAL AUGMENT, NONPOROUS, SIZE 4 X 15MM
• B278KTAGB410E0: TIBIAL AUGMENT, NONPOROUS, SIZE 4 X 10MM
• B278KTAGB405E0: TIBIAL AUGMENT, NONPOROUS, SIZE 4 X 5MM