Skip to content

AGILON® stem cementless 38512012

by implantcast GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number04048844331351 UDI-DI Date18 Nov 2020ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AGILON® stem cementless
Generic Name
Uncoated shoulder humeral stem prosthesis
Model / Reference
38512012
Primary DI / UDI-DI
04048844331351
FDA Product Code
HSD
GMDN Term
Uncoated shoulder humeral stem prosthesis
Device Class
Class II
Regulation Number
888.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Uncoated shoulder humeral stem prosthesis

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

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