AccessGUDID - DEVICE: ECHO XL TiNano OLIF (B521108826120812)

GUDID

Device Identifier (DI) Information

Brand Name: ECHO XL TiNano OLIF
Version or Model: 108026120812
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 108826120812
Company Name: AURORA SPINE, INC.

Primary DI Number: B521108826120812
Issuing Agency: HIBCC
Commercial Distribution End Date: February 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 079119091 *Terms of Use

Device Description: ECHO XL TiNano OLIF 26mm X 12mm X 8 X 12mm

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?
60847	Polymeric spinal fusion cage, sterile	A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133967	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 12 Millimeter
Angle: 8 degree
Width: 12 Millimeter
Length: 26 Millimeter

Device Record Status

Public Device Record Key: fc970304-6189-4ca1-831d-87ed8a7e0799
Public Version Date: February 04, 2019
Public Version Number: 5
DI Record Publish Date: February 01, 2017