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Global Advantage 1128-52-020

by Depuy Orthopaedics, Inc.

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 Number10603295005216 UDI-DI Date24 Sep 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  • Withdrawn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
Global Advantage
Generic Name
Stem-fixed metallic humeral head prosthesis
Model / Ref / Catalog
1128-52-020, 112852020
Primary DI / UDI-DI
10603295005216
510(k) Number
FDA Product Code
HSD, KWT
GMDN Term
Stem-fixed metallic humeral head prosthesis
Device Class
Class II
Regulation Number
888.3690, 888.3650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stem-fixed metallic humeral head prosthesis

Cleared under the same submission (K984541)

Show all (12)

Other devices from Depuy Orthopaedics, Inc.

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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