AccessGUDID - DEVICE: HARRIER-SA Lumbar Interbody System (00840996171434)

GUDID

Device Identifier (DI) Information

Brand Name: HARRIER-SA Lumbar Interbody System
Version or Model: S-YT10-26321515
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Choice Spine, LP

Primary DI Number: 00840996171434
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078293017 *Terms of Use

Device Description: HARRIER-SA,ST,SPACER,Ti,26X32X15,15DEG

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?
43084	Intervertebral-body internal spinal fixation system	A group of sterile implantable devices designed to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The system components are typically made of medical grade titanium and consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the centre of each plate, and a braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral fusion device with bone graft, lumbar
OVD	Intervertebral fusion device with integrated fixation, lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180519	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
Width: 32 Millimeter
Depth: 26 Millimeter
Height: 15 Millimeter

Device Record Status

Public Device Record Key: 61b4b36d-7439-40fb-9404-3a2a8f1d49aa
Public Version Date: September 20, 2018
Public Version Number: 1
DI Record Publish Date: August 20, 2018