AccessGUDID - DEVICE: VIA Spinous Process Fixation System (M7404400002)

GUDID

Device Identifier (DI) Information

Brand Name: VIA Spinous Process Fixation System
Version or Model: 34-01-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 440-0002
Company Name: SPINEOLOGY INC.

Primary DI Number: M7404400002
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033014361 *Terms of Use

Device Description: Male Plate

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
61533	Interspinous spinal fixation implant	An implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PEK	Spinous process plate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142213	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 11 Millimeter
Device Size Text, specify: 11x35

Device Record Status

Public Device Record Key: 11bfb190-ea04-4f6e-9407-5cda7c4502cf
Public Version Date: July 23, 2024
Public Version Number: 5
DI Record Publish Date: March 09, 2015