Skip to content

AEQUALIS™ PerFORM DWE421

by Tornier, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number03700386937514 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: not 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  • Withdrawn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
AEQUALIS™ PerFORM
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated
Model / Reference
DWE421
Primary DI / UDI-DI
03700386937514
FDA Product Code
KWS
GMDN Term
Shoulder glenoid fossa prosthesis, prefabricated
Device Class
Class II
Regulation Number
888.3660
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Shoulder glenoid fossa prosthesis, prefabricated

Cleared under the same submission (K111902)

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Manufacturing Date: No