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Tornier Perform® Anatomic Augmented Glenoid DWK403LA35S

by Tornier, 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 Number00846832091676 UDI-DI Date13 Apr 2022ListedStatusListed 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  • Withdrawn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
Tornier Perform® Anatomic Augmented Glenoid
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated
Model / Ref / Catalog
DWK403LA35S
Primary DI / UDI-DI
00846832091676
510(k) Number
FDA Product Code
KWS
GMDN Term
Shoulder glenoid fossa prosthesis, prefabricated
Device Class
Class II
Regulation Number
888.3660
GUDID distribution status
In Commercial Distribution
Size
Angle — 35 degree

Related devices

Category: Shoulder glenoid fossa prosthesis, prefabricated

Cleared under the same submission (K160975)

Show all (12)

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Properties

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