Model: 65-C-1214-10-6L
Catalog: 65-C-1214-10-6L
DI: 00840311212835
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
Fortilink-C, 12x14, 10mm, 6L
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ff30d1e9-074d-44e8-8251-eec1dbf634f9
Distribution Status:
In Commercial Distribution
DUNS Number:
081224143
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 - Device ID:
00846468080389
Item #1 - Device ID Type:
Previous
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00840311212835
Item #2 - Device ID Type:
Primary
Item #2 - Device ID 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
MQP
Spinal vertebral body replacement device
ODP
Intervertebral fusion device with bone graft, cervical
Premarket Submissions
Submission Number:
K163673
Supplement Number:
000
Device Sizes
Device Size - Size Text:
12mm (D), 14mm (W), 10mm (H), 6° Lordosis
Device Size - Size Type:
Device Size Text, specify