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U1 Hip System, Bipolar Cup Liner 1601-1057

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 Number04711605564885 UDI-DI Date24 Oct 2015ListedStatusListed 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  • Withdrawn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 Hip System, Bipolar Cup Liner
Generic Name
Bipolar femoral head outer component, hemiarthroplasty
Model / Ref / Catalog
1601-1057
Primary DI / UDI-DI
04711605564885
510(k) Number
FDA Product Code
KWY
GMDN Term
Bipolar femoral head outer component, hemiarthroplasty
Device Class
Class II
Regulation Number
888.3390
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 57 Millimeter

Related devices

Category: Bipolar femoral head outer component, hemiarthroplasty

Cleared under the same submission (K050269)

Show all (12)

Other devices from United Orthopedic Corp.

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Properties

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

Other properties (8)

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