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U1 Total Hip System 1403-6046

by United Orthopedic Corp.

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 Number04719872168287 UDI-DI Date16 Jun 2022ListedStatusListed 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  • Withdrawn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
U1 Total Hip System
Generic Name
Femoral stem prosthesis trial
Model / Ref / Catalog
1403-6046
Primary DI / UDI-DI
04719872168287
510(k) Number
FDA Product Code
LWJ, MEH
GMDN Term
Femoral stem prosthesis trial
Device Class
Class II
Regulation Number
888.3360, 888.3353
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Femoral stem prosthesis trial

Cleared under the same submission (K050262)

Show all (12)

Other devices from United Orthopedic Corp.

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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