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Expert Tibia Nail, Ø8mm x Length 255mm, Titanium, Sterile TI-520-08-255-S

by Auxein Medical Private Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08903993114377 UDI-DI Date1 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Expert Tibia Nail, Ø8mm x Length 255mm, Titanium, Sterile
Generic Name
Femur intramedullary nail
Model / Reference
TI-520-08-255-S
Primary DI / UDI-DI
08903993114377
510(k) Number
FDA Product Code
HWC
GMDN Term
Femur intramedullary nail
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K210792)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No