Device
T NanoVy™ Ti IBF, Sterile, 9x27, 0°, 10mm, PEEK Optima LT1 - CP Ti
Manufacturer
VY SPINE LLC
VY SPINE LLC
Model: 03-T-0927-0-10-PET-R
DI: 00840283403507
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
T NanoVy™ Ti IBF, Sterile, 9x27, 0°, 10mm, PEEK Optima LT1 - CP Ti
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
abfd1fbf-82af-489e-95d0-bdd150da2668
Distribution Status:
In Commercial Distribution
DUNS Number:
049592888
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840283403507
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61230
Name: Metal-polymer composite spinal interbody fusion cage
Definition:
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.
FDA Product Codes
MAX
Intervertebral Fusion Device With Bone Graft, Lumbar
MQP
Spinal Vertebral Body Replacement Device
Premarket Submissions
Submission Number:
K223412
Supplement Number:
000