ELEOS Limb Salvage System FB-16152-03M

GUDID B278FB1615203M0

ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 36MM COLLAR, 16MM X 152MM

ONKOS SURGICAL, INC.

Body femoral/tibial extension stem, uncoated
Primary Device IDB278FB1615203M0
NIH Device Record Keyabde3fbc-6b0d-47fc-a7fd-299bd84d4326
Commercial Distribution StatusIn Commercial Distribution
Brand NameELEOS Limb Salvage System
Version Model NumberFB-16152-03M
Catalog NumberFB-16152-03M
Company DUNS080254074
Company NameONKOS SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com
Phone+1(844)767-2766
Emailcustomerservice@onkossurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB278FB1615203M0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

[B278FB1615203M0]

Radiation Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-21
Device Publish Date2022-03-11

On-Brand Devices [ELEOS Limb Salvage System]

B278SB4044V03M0MODULAR REDUCED RESECTION COLLAR, 40MM X 44MM
B278SB3640V03M0MODULAR REDUCED RESECTION COLLAR, 36MM X 40MM
B278HR3000003M0ELEOS MODULAR COLLAR LOCKING RING
B278HR3000103M0ELEOS MODULAR COLLAR LOCKING RING AND IMPACTOR TIP
B278FS2112003M0ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 36MM COLLAR, 21MM X 120MM
B278FS2012003M0ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 36MM COLLAR, 20MM X 120MM
B278FS1912003M0ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 36MM COLLAR, 19MM X 120MM
B278FS1812003M0ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 36MM COLLAR, 18MM X 120MM
B278FS1712003M0ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 36MM COLLAR, 17MM X 120MM
B278FS1612003M0ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 36MM COLLAR, 16MM X 120MM
B278FS1512003M0ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 32MM COLLAR, 15MM X 120MM
B278FS1412003M0ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 32MM COLLAR, 14MM X 120MM
B278FS1312003M0SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 28MM COLLAR, 13MM X 120MM
B278FS1212003M0ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 28MM COLLAR, 12MM X 120MM
B278FS1112003M0ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 28MM COLLAR, 11MM X 120MM
B278FB2115203M0ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 36MM COLLAR, 21MM X 15
B278FB2015203M0ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 36MM COLLAR, 20MM X 15
B278FB1915203M0ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 36MM COLLAR, 19MM X 15
B278FB1815203M0ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 36MM COLLAR, 18MM X 15
B278FB1715203M0ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 36MM COLLAR, 17MM X 15
B278FB1615203M0ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 36MM COLLAR, 16MM X 15
B278FB1515203M0ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 32MM COLLAR, 15MM X 15
B278FB1415203M0ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 32MM COLLAR, 14MM X 15
B278FB1315203M0ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 28MM COLLAR, 13MM X 15
B278FB1215203M0ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 28MM COLLAR, 12MM X 15
B278FB1115203M0ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 28MM COLLAR, 11MM X 15
B278CS1712003M0ELEOS SEGMENTAL STEM, CEMENTED, STRAIGHT, FLUTED, 36MM COLLAR, 17MM X 120MM
B278CS1512003M0ELEOS SEGMENTAL STEM, CEMENTED, STRAIGHT, FLUTED, 32MM COLLAR, 15MM X 120MM
B278CS1312003M0ELEOS SEGMENTAL STEM, CEMENTED, STRAIGHT, FLUTED, 28MM COLLAR, 13MM X 120MM
B278CS1112003M0ELEOS SEGMENTAL STEM, CEMENTED, STRAIGHT, FLUTED, 28MM COLLAR, 11MM X 120MM
B278CS1010003M0ELEOS SEGMENTAL STEM, CEMENTED, STRAIGHT, FLUTED, 24MM COLLAR, 10MM X 100MM
B278CS0910003M0ELEOS SEGMENTAL STEM, CEMENTED,STRAIGHT, FLUTED, 24MM COLLAR 9MM X 100MM
B278CB1715203M0ELEOS SEGMENTAL STEM, CEMENTED, BOWED, FLUTED, 36MM COLLAR, 17MM X 152MM
B278CB1515203M0ELEOS SEGMENTAL STEM, CEMENTED, BOWED, FLUTED, 32MM COLLAR, 15MM X 152MM
B278CB1315203M0ELEOS SEGMENTAL STEM, CEMENTED, BOWED, FLUTED, 28MM COLLAR, 13MM X 152MM
B278CB1115203M0ELEOS SEGMENTAL STEM, CEMENTED, BOWED, FLUTED, 28MM COLLAR, 11MM X 152MM
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