AccessGUDID - DEVICE: Valeo Spacer System (M555124001008)

GUDID

Device Identifier (DI) Information

Brand Name: Valeo Spacer System
Version or Model: B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 12.400.1008
Company Name: AMEDICA CORPORATION

Primary DI Number: M555124001008
Issuing Agency: HIBCC
Commercial Distribution End Date: September 27, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 028629553 *Terms of Use

Device Description: Valeo II TL, Round, 11x30, 8° , 8mm

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?
61958	Ceramic spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of a ceramic material [e.g., silicon nitride] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 8 Millimeter
Width: 30 Millimeter
Length: 11 Millimeter

Device Record Status

Public Device Record Key: 69603350-b24f-499b-983d-ee39f8011b5b
Public Version Date: November 20, 2024
Public Version Number: 6
DI Record Publish Date: December 29, 2017