Model: 6800514
Catalog: 6800514
DI: 00887517645166
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-25
Current Version: 2026-05-04
Description
CoRoent XL-W Trial Rasp, 14x22x55mm
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:
1c5bfa8c-461a-42ac-988a-84aaad13701f
Distribution Status:
In Commercial Distribution
DUNS Number:
053950783
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:
00887517645166
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
MAX
Intervertebral fusion device with bone graft, lumbar
MQP
Spinal vertebral body replacement device
Premarket Submissions
Submission Number:
K120918
Supplement Number:
000