Model: 1141308P2
Catalog: 1141308P2
DI: 00887517867292
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Modulus TLIF-A, 14x11x30mm 8°
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:
8cdc181d-4068-4ccf-a397-35499acbc0da
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:
00887517867292
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
PHM
Intervertebral fusion device with bone graft, thoracic
Premarket Submissions
Submission Number:
K172341
Supplement Number:
000