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U2 Femoral head, 4/5 polished, Ø32mm, +7.5mm 1206-5632

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 Number04719872155553 UDI-DI Date6 Oct 2017ListedStatusListed 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  • Withdrawn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
U2 Femoral head, 4/5 polished, Ø32mm, +7.5mm
Generic Name
Metal-on-polyethylene total hip prosthesis
Model / Ref / Catalog
1206-5632
Primary DI / UDI-DI
04719872155553
510(k) Number
FDA Product Code
LPH
GMDN Term
Metal-on-polyethylene total hip prosthesis
Device Class
Class II
Regulation Number
888.3358
GUDID distribution status
In Commercial Distribution

Related devices

Category: Metal-on-polyethylene total hip prosthesis

Cleared under the same submission (K162957)

Show all (12)

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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