Model: 21001114120502
Catalog: 21001114120502
DI: 04719878784672
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-C Interbody System
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fdbd536a-0a86-49a8-a060-cd9f4adac7b1
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:
04719878784672
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
ODP
Intervertebral Fusion Device With Bone Graft, Cervical
Premarket Submissions
Submission Number:
K220261
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:
Length
Item #3 - Size - @attributes - Unit:
Millimeter
Item #3 - Size - @attributes - Value:
5
Item #3 - Size Type:
Height