Device
ORIO-3D Trabecular Ti Stand-Alone ALIF Cage, LG, 28x38x14 mm, 20 deg.
Manufacturer
SPINECRAFT, LLC
SPINECRAFT, LLC
Model: SP-LPS-A220-14
Catalog: SP-LPS-A220-14
DI: 00193082166785
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
ORIO-3D Trabecular Ti Stand-Alone ALIF Cage, LG, 28x38x14 mm, 20 deg.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ba87ad40-c886-44d0-ad32-0fe8bfad6020
Distribution Status:
In Commercial Distribution
DUNS Number:
783908713
Device Count:
1
DM Exempt:
Yes
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:
Yes
Identifiers
Device ID:
00193082166785
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38161
Name: Metallic 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 in order 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 cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] 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
OVD
Intervertebral fusion device with integrated fixation, lumbar
ODP
Intervertebral fusion device with bone graft, cervical
Premarket Submissions
Submission Number:
K253260
Supplement Number:
000