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Visionaire V0100012

by Smith & Nephew, Inc.

Visionaire V0100012 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 29 Aug 2015 (UDI-DI 03596010653116), 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 Number03596010653116 UDI-DI Date29 Aug 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 03596010653116 listed 29 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082358
  2. Listed FDA GUDID 03596010653116

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  • Withdrawn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 prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
V0100012
Primary DI / UDI-DI
03596010653116
510(k) Number
FDA product code
JWH
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, 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

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)