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UTF Hip Stem 9106-6011-RT

by United Orthopedic Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number04719872167235 UDI-DI Date24 Jun 2022ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1385-2013 FDA Class II initiated 20 Feb 2013

    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
UTF Hip Stem
Generic Name
Orthopaedic broach
Model / Ref / Catalog
9106-6011-RT
Primary DI / UDI-DI
04719872167235
510(k) Number
FDA Product Code
LPH, KWY, LZO
GMDN Term
Orthopaedic broach
Device Class
Class II
Regulation Number
888.3358, 888.3390, 888.3353
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic broach

Cleared under the same submission (K110245)

Show all (12)

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

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