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Cadence Total Ankle System 10203194

by Smith & Nephew, Inc.

Cadence Total Ankle System 10203194 is a Class I device made by Smith & Nephew, Inc., listed in FDA GUDID since 2 Feb 2023 (UDI-DI 00885556851111), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885556851111 UDI-DI Date2 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Cadence Total Ankle System
Generic name
Joint prosthesis implantation kit, reusable
Model / Ref / Catalog
10203194
Primary DI / UDI-DI
00885556851111
FDA product code
LXH
GMDN term
Joint prosthesis implantation kit, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)