Model: 03.30.10.2164
DI: 07630542786259
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
ALIF Inserter Oblique 15°-W35
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:
3b07c75b-1642-48de-bc7c-2f5dfcd64de2
Distribution Status:
In Commercial Distribution
DUNS Number:
488227125
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07630542786259
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44054
Name: Orthopaedic surgical procedure kit, non-medicated, reusable
Definition:
A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.
FDA Product Codes
OVD
Intervertebral fusion device with integrated fixation, lumbar
Premarket Submissions
Submission Number:
K254202
Supplement Number:
000