Model: 02-ITL-1411-07
DI: 00840283405570
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
IBF Trial, Line to Line, 14x11, 7mm
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
46577016-c938-4284-a508-cfb6d90f7d46
Distribution Status:
In Commercial Distribution
DUNS Number:
049592888
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840283405570
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44788
Name: Spinal implant trial
Definition:
A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.
FDA Product Codes
ODP
Intervertebral Fusion Device With Bone Graft, Cervical
OVE
Intervertebral Fusion Device With Integrated Fixation, Cervical
Premarket Submissions
Submission Number:
K212715
Supplement Number:
000