AccessGUDID - DEVICE: Irix-A Lumbar Integrated Fusion System (M697C08000111)

GUDID

Device Identifier (DI) Information

Brand Name: Irix-A Lumbar Integrated Fusion System
Version or Model: C080-0011
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xtant Medical Holdings, Inc.

Primary DI Number: M697C08000111
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081224143 *Terms of Use

Device Description: 15 MM SPECIALTY 33X26X8 DEG IRIX A MODULAR TRIAL HEAD

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:	No
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
HWT	TEMPLATE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam 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: f0304fe9-826d-4ca7-bdfb-fe1f64b1dbae
Public Version Date: June 03, 2021
Public Version Number: 4
DI Record Publish Date: February 23, 2016