Device
2.0/2.3mm Compression Plate, 6H, Suitable 2.3mm screw
Manufacturer
MICROWARE PRECISION CO., LTD.
MICROWARE PRECISION CO., LTD.
Model: T1-55-15585
DI: 04719879390247
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
2.0/2.3mm Compression Plate, 6H, Suitable 2.3mm screw
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:
8030b4d2-6c06-4264-81ec-ab2bc86b06aa
Distribution Status:
In Commercial Distribution
DUNS Number:
658650833
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:
04719879390247
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46642
Name: Craniofacial fixation plate, non-bioabsorbable, non-customized
Definition:
A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate.
FDA Product Codes
JEY
Plate, Bone
Premarket Submissions
Submission Number:
K220360
Supplement Number:
000