Device
Expert Tibia Nail, Ø8mm x Length 270mm, Titanium, Sterile
Manufacturer
Auxein Medical Private Limited
Auxein Medical Private Limited
Model: TI-520-08-270-S
DI: 08903993114384
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
Expert Tibia Nail, Ø8mm x Length 270mm, Titanium, Sterile
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
46cea8b4-5224-4db4-a476-259182daa4c0
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:
08903993114384
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 33187
Name: Femur intramedullary nail
Definition:
A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.
FDA Product Codes
HWC
Screw, Fixation, Bone
Premarket Submissions
Submission Number:
K210792
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