AccessGUDID - DEVICE: Vu a-POD™ (10889981037857)

GUDID

Device Identifier (DI) Information

Brand Name: Vu a-POD™
Version or Model: 21-11-3912
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-11-3912
Company Name: Seaspine Orthopedics Corporation

Primary DI Number: 10889981037857
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: 39x30 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?
61325	Bone-screw internal spinal fixation system, non-sterile	An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.	Obsolete	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: 39x30 12mm

Device Record Status

Public Device Record Key: e8a4b6d0-26b6-44e2-94ab-e6559526babc
Public Version Date: December 30, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2015