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Visionaire V0200011

by Smith & Nephew, Inc.

Visionaire V0200011 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K082358 on 25 Nov 2008 and listed in FDA GUDID since 28 Sep 2015 (UDI-DI 00885556583012), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K082358

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885556583012 UDI-DI Date28 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082358 Date25 Nov 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082358 decided 25 Nov 2008 Active
  • FDA GUDID UDI-DI 00885556583012 listed 28 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082358
  2. Listed FDA GUDID 00885556583012

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Visionaire
Generic name
Orthopaedic implant aiming/guiding block, reusable
Model / Ref / Catalog
V0200011
Primary DI / UDI-DI
00885556583012
510(k) Number
FDA product code
JWH
GMDN term
Orthopaedic implant aiming/guiding block, reusable
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant aiming/guiding block, reusable

Cleared under the same submission (K082358)

and 8 more cleared under K082358

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)