Device
2.4mm Wise-Lock “T” Distal Radius Dorsal Plate (3 Head Holes),4 Holes, Titanium, Sterile
Manufacturer
Auxein Medical Private Limited
Auxein Medical Private Limited
Model: TI-M08.04-S
DI: 08903993595190
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
2.4mm Wise-Lock “T” Distal Radius Dorsal Plate (3 Head Holes),4 Holes, Titanium, Sterile
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7be6367b-ffd4-4c0d-b3ee-57b4f74ed058
Distribution Status:
In Commercial Distribution
DUNS Number:
872194615
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:
08903993595190
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46647
Name: Orthopaedic fixation plate, non-bioabsorbable
Definition:
A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.
FDA Product Codes
HRS
Plate, Fixation, Bone
Premarket Submissions
Submission Number:
K211324
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
10
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Storage Environment Temperature