AccessGUDID - DEVICE: Valencia Pedicle Screw System (B41794400301)

GUDID

Device Identifier (DI) Information

Brand Name: Valencia Pedicle Screw System
Version or Model: 944-0030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Altus Spine, LLC

Primary DI Number: B41794400301
Issuing Agency: HIBCC
Commercial Distribution End Date: December 27, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 078331322 *Terms of Use

Device Description: 3.0mm Pedicle Screw Spacer

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?
61531	Lumbar decompression interspinous spacer	A device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MNH	Orthosis, spondylolisthesis spinal fixation
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 3 Millimeter

Device Record Status

Public Device Record Key: dbd12291-80bb-4e90-811f-7e3ae5e5bde2
Public Version Date: August 16, 2024
Public Version Number: 3
DI Record Publish Date: October 28, 2016