AccessGUDID - DEVICE: Vu a-POD™ (10889981037758)

GUDID

Device Identifier (DI) Information

Brand Name: Vu a-POD™
Version or Model: 21-11-3112
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-11-3112
Company Name: Seaspine Orthopedics Corporation

Primary DI Number: 10889981037758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: 31x24 12mm Spin Plate. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage.

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:	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?
61230	Metal-polymer composite 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 to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated device made of a non-bioabsorbable synthetic polymer with a metallic coating 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 packaged with the cage.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080822	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
Device Size Text, specify: 31x24 12mm

Device Record Status

Public Device Record Key: b0cb82b1-9361-4dcb-8ec3-2ac98f63af23
Public Version Date: July 21, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2015