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Double ENDOBUTTON Fixation Device

by Smith & Nephew, Inc.

510(k) K183232

Double ENDOBUTTON Fixation Device is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K183232 on 12 Mar 2019, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183232 Date12 Mar 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HTN
FDA applicant
Smith and Nephew, Inc.
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K183232

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K183232
UDI-DISize and differences
Double ENDOBUTTON 71934989
Smith & Nephew, Inc.
71934989 / 7193498900885556486146 —On the market
Double ENDOBUTTON 71934990
Smith & Nephew, Inc.
71934990 / 7193499000885556486191 —On the market
Double ENDOBUTTON 71934993
Smith & Nephew, Inc.
71934993 / 7193499300885556424544 —On the market
Double ENDOBUTTON 71935024
Smith & Nephew, Inc.
71935024 / 7193502400885556467640 —On the market

Similar devices

Other devices filed under FDA product code HTN (Washer, Bolt Nut).

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