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Evos 71175607

by Smith & Nephew, Inc.

Evos 71175607 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K203405 on 27 Jan 2021 and listed in FDA GUDID since 19 May 2021 (UDI-DI 00885556765753), 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) K203405

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 Number00885556765753 UDI-DI Date19 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203405 Date27 Jan 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203405 decided 27 Jan 2021 Active
  • FDA GUDID UDI-DI 00885556765753 listed 19 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203405
  2. Listed FDA GUDID 00885556765753

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Evos
Generic name
Bone tap, single-use
Model / Ref / Catalog
71175607
Primary DI / UDI-DI
00885556765753
510(k) Number
FDA product code
HRS
GMDN term
Bone tap, single-use
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone tap, single-use

Cleared under the same submission (K203405)

and 8 more cleared under K203405

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

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