AccessGUDID - DEVICE: ELEOS Limb Salvage System (B278FB2115203M0)

GUDID

Device Identifier (DI) Information

Brand Name: ELEOS Limb Salvage System
Version or Model: FB-21152-03M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FB-21152-03M
Company Name: ONKOS SURGICAL, INC.

Primary DI Number: B278FB2115203M0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080254074 *Terms of Use

Device Description: ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 36MM COLLAR, 21MM X 152MM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61561	Body femoral/tibial extension stem, uncoated	A sterile implantable device intended to provide an extension of, or coupling with, other components of a modular femoral/tibial prosthesis in the medullary canal to compensate for bone loss during revision arthroplasty or bone resection. The device is a solid/dense body made of uncoated metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Fixation devices for implantation (e.g., screws and bolts) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161520	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4a1c9b5c-c623-451e-b6df-455f5264f674
Public Version Date: May 25, 2022
Public Version Number: 2
DI Record Publish Date: March 11, 2022