Model: TP.PL.0116
Catalog: TP.PL.0116
DI: 00840354203685
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
1 level Anterior Cervical Plate 16mm
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:
b8088677-da26-4809-bc5f-c16bd8b0763d
Distribution Status:
In Commercial Distribution
DUNS Number:
094374525
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
00840354203685
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46653
Name: Spinal fixation plate, non-bioabsorbable
Definition:
A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.
FDA Product Codes
KWQ
Appliance, Fixation, Spinal Intervertebral Body