FDA.reportPublic FDA data

510(k) K183232

Device
Double ENDOBUTTON Fixation Device
Applicant
Smith And Nephew, Inc.
510(k) number
K183232
Product code
HTN  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-12
Date received
2018-11-20
Regulation
888.3030
Classification name
Washer, Bolt Nut
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dharaben Desai
Address
150 Minuteman Rd. Andover MA US 01810 01810

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HTN  #

510(k), Device, Applicant table
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K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)2025-10-29
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K243624Acu-Sinch Knotless MiniAcumed, LLC2025-01-23
K242091Bolo Button SystemFusion Orthopedics2024-12-23
K243408TACTIX Vector Syndesmosis SystemVilex, LLC2024-11-27
K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.2024-11-01
K240035TACTIX Vector Syndesmosis SystemVilex, LLC2024-08-01
K240947TENSOR® Suture Button SystemGlobus Medical, Inc.2024-06-03
K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company2024-02-02
K232780CC-Clip® Implant SystemCc-Instruments, Inc.2023-12-18
K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.2023-10-06
K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.2022-08-22
K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.2022-06-06