AccessGUDID - DEVICE: VIA Spinous Process Fixation System (M7404400034)

GUDID

Device Identifier (DI) Information

Brand Name: VIA Spinous Process Fixation System
Version or Model: 34-06-17
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 440-0034
Company Name: SPINEOLOGY INC.

Primary DI Number: M7404400034
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033014361 *Terms of Use

Device Description: 15mm Rasp

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:	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?
35559	Bone file/rasp, manual, reusable	A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	Active	false

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 15 Millimeter
Device Size Text, specify: 15

Device Record Status

Public Device Record Key: 713706a0-9b5d-4dfb-8d3b-0fbcac5209fb
Public Version Date: July 23, 2024
Public Version Number: 4
DI Record Publish Date: February 25, 2015