Skip to content

Chs 124121

by Smith & Nephew, Inc.

Chs 124121 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K213126 on 29 Sep 2022 (2 earlier submissions) and listed in FDA GUDID since 25 Aug 2015 (UDI-DI 03596010072818), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213126 Date29 Sep 2022DecidedStatusActive
United StatesGUDID listing Number03596010072818 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213126 decided 29 Sep 2022 Active· +2 more in the status table
  • FDA GUDID UDI-DI 03596010072818 listed 25 Aug 2015 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K993289
  2. Listed FDA GUDID 03596010072818
  3. Cleared FDA 510(k) K210837
  4. Cleared FDA 510(k) K213126

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Chs
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
124121
Primary DI / UDI-DI
03596010072818
510(k) Number
FDA product code
KTT
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K210837)

and 8 more cleared under K210837

Cleared under the same submission (K213126)

and 8 more cleared under K213126

Similar devices in this category

Other devices filed under Orthopaedic fixation plate, non-bioabsorbable.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

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