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Flex-Thread Ulna FUA 100

by Flower Orthopedics Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00840118122962 UDI-DI Date31 Jan 2023ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Flex-Thread Ulna
Generic Name
Orthopaedic implant aiming arm
Model / Reference
FUA 100
Primary DI / UDI-DI
00840118122962
FDA Product Code
HTJ
GMDN Term
Orthopaedic implant aiming arm
Device Class
Class I
Regulation Number
888.4300
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant aiming arm

Other devices from Flower Orthopedics Corporation

See all devices from Flower Orthopedics Corporation →

Properties

  • Prescription Use
  • Premarket Exempt

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No