Model: 6791812P2
Catalog: 6791812P2
DI: 00887517051929
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
CoRoent SI Screw, 4.5x12mm Rescue
Sterilization
Method Types - Sterilization Method:
Radiation Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
83107829-2e1f-4aca-bf70-3a03fd6a8980
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00887517051929
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60762
Name: Polymeric 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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 included with the device.
FDA Product Codes
MAX
Intervertebral fusion device with bone graft, lumbar
Premarket Submissions
Submission Number:
K140319
Supplement Number:
000