Model: AIIN-0208-0001
Catalog: 0208-0001
DI: 00840185382115
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Distribution End: 2026-05-14
Description
Implants Container
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:
bed14e53-4c4b-42e4-b063-afe7ad079ab5
Distribution Status:
Not in Commercial Distribution
DUNS Number:
868354728
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:
00840185382115
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 67309
Name: Spinal fixation implant/sterilization container set
Definition:
A collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.
FDA Product Codes
NKB
Thoracolumbosacral Pedicle Screw System
Premarket Submissions
Submission Number:
K232607
Supplement Number:
000