Device
SA Cervical, 14W x 12D x 9H x 12°, HA & ß-TCP PEEK, Ti 6Al 4V (ELI), Ta
Manufacturer
INNO Holdings, Inc.
INNO Holdings, Inc.
Model: 51-140912
DI: M711511409120
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
SA Cervical, 14W x 12D x 9H x 12°, HA & ß-TCP PEEK, Ti 6Al 4V (ELI), Ta
Sterilization
Method Types - Sterilization Method:
Radiation Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e3ff976d-6f2c-4b15-b390-2cacdb082aaa
Distribution Status:
In Commercial Distribution
DUNS Number:
141620464
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
Item #1 - Pkg Type:
Carton
Item #1 - Device ID:
M711511409121
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
M711511409120
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
M711511409120
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
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
OVE
Intervertebral Fusion Device With Integrated Fixation, Cervical
Premarket Submissions
Submission Number:
K250076
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
14
Item #1 - Size Type:
Width
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
12
Item #2 - Size Type:
Depth
Item #3 - Size - @attributes - Unit:
Millimeter
Item #3 - Size - @attributes - Value:
9
Item #3 - Size Type:
Height
Item #4 - Size Text:
12 Degrees
Item #4 - Size Type:
Device Size Text, specify