Model: 21001009261104
Catalog: 21001009261104
DI: 04710281445389
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
NEST Interbody System
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ce1ccecc-e51b-4295-86ad-6816bf7d5efc
Distribution Status:
In Commercial Distribution
DUNS Number:
657397790
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:
04710281445389
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
Premarket Submissions
Submission Number:
K180230
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
9
Item #1 - Size Type:
Width
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
26
Item #2 - Size Type:
Length
Item #3 - Size - @attributes - Unit:
Millimeter
Item #3 - Size - @attributes - Value:
11
Item #3 - Size Type:
Height
Item #4 - Size - @attributes - Unit:
degree
Item #4 - Size - @attributes - Value:
12
Item #4 - Size Type:
Angle