FDA.report

510(k) K223933

Device
Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
Applicant
Exactech, Inc.
510(k) number
K223933
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-25
Date received
2022-12-30
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Valdimir Talley
Address
2320 NW 66th Ct. Gainesville FL US 32653 32653

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
10885862595447EquinoxeExactech, Inc.2024-04-12
10885862595454EquinoxeExactech, Inc.2024-04-12
10885862595461EquinoxeExactech, Inc.2024-04-12
10885862595478EquinoxeExactech, Inc.2024-04-12
10885862595485EquinoxeExactech, Inc.2024-04-12
10885862591296EquinoxeExactech, Inc.2024-03-26
10885862591432EquinoxeExactech, Inc.2024-03-26
10885862591302EquinoxeExactech, Inc.2024-03-26
10885862591319EquinoxeExactech, Inc.2024-03-26
10885862591326EquinoxeExactech, Inc.2024-03-26
10885862591333EquinoxeExactech, Inc.2024-03-26
10885862591340EquinoxeExactech, Inc.2024-03-26
10885862591371EquinoxeExactech, Inc.2024-03-26
10885862591388EquinoxeExactech, Inc.2024-03-26
10885862591395EquinoxeExactech, Inc.2024-03-26
10885862591425EquinoxeExactech, Inc.2024-03-26
10885862591487EquinoxeExactech, Inc.2024-03-26
10885862591289EquinoxeExactech, Inc.2024-03-26
10885862591272EquinoxeExactech, Inc.2024-03-26
10885862591265EquinoxeExactech, Inc.2024-03-26
10885862591258EquinoxeExactech, Inc.2024-03-26
10885862591241EquinoxeExactech, Inc.2024-03-26
10885862591234EquinoxeExactech, Inc.2024-03-26
10885862591203EquinoxeExactech, Inc.2024-03-26
10885862591197EquinoxeExactech, Inc.2024-03-26
10885862591180EquinoxeExactech, Inc.2024-03-26
10885862588845EquinoxeExactech, Inc.2024-03-26
10885862588838EquinoxeExactech, Inc.2024-03-26
10885862592125EquinoxeExactech, Inc.2024-03-26
10885862606020EquinoxeExactech, Inc.2024-03-26

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K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC2026-05-09
K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.2026-04-30
K260411PC Fix SystemChest Wall Innovations, Inc.2026-04-24
K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG2026-04-24
K260054I.T.S. PRS Phoenix III.T.S. GmbH2026-04-24
K260090SMART Osteotomy SystemActis Medical Pty., Ltd.2026-04-10
K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.2026-04-01
K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.2026-03-25
K260274Airlock® Ankle Plating SystemNovastep SAS2026-03-25
K254253LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AG2026-03-24
K254288Clavicle Fixation SystemSkeletal Dynamics, Inc.2026-03-23
K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.2026-03-19
K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-03-17
K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.2026-03-17
K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG2026-03-16