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Alliance Humeral Bearings 11007519

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024705029 UDI-DI Date10 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Alliance Humeral Bearings
Generic Name
Polyethylene reverse shoulder prosthesis cup
Model / Ref / Catalog
11007519
Primary DI / UDI-DI
00889024705029
510(k) Number
FDA Product Code
HSD, PHX, KWT, KWS, MBF
GMDN Term
Polyethylene reverse shoulder prosthesis cup
Device Class
Class II
Regulation Number
888.3690, 888.3660, 888.3650, 888.3670
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K253592)

Show all (12)

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

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

Other properties (7)

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