FDA.report

510(k) K230204

Device
ALPHALOK Plating System
Applicant
Vilex, LLC
510(k) number
K230204
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-25
Date received
2023-01-25
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
Brock Johnson
Address
111 Moffitt St. Mcminnville TN US 37110 37110

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
00841731133991ALPHALOK Plating SystemVILEX LLC2024-02-19
00841731134004ALPHALOK Plating SystemVILEX LLC2024-02-19
00841731134011ALPHALOK Plating SystemVILEX LLC2024-02-19
00841731134028ALPHALOK Plating SystemVILEX LLC2024-02-19
00841731134035ALPHALOK Plating SystemVILEX LLC2024-02-19
00841731134042ALPHALOK Plating SystemVILEX LLC2024-02-19
00841731134059ALPHALOK Plating SystemVILEX LLC2024-02-19
00841731134066ALPHALOK Plating SystemVILEX LLC2024-02-19
00841731136510ALPHALOK Plating SystemVILEX LLC2024-02-19
00841731133908ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731133915ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731133892ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731133885ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731133878ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731131485ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731131478ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731131461ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731131454ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731131447ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731131430ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731131423ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731131416ALPHALOK Plating SystemVILEX LLC2024-02-12
00841731131294ALPHALOK Plating SystemVILEX LLC2023-08-11
00841731131393ALPHALOK Plating SystemVILEX LLC2023-08-11
00841731131386ALPHALOK Plating SystemVILEX LLC2023-08-11
00841731131379ALPHALOK Plating SystemVILEX LLC2023-08-11
00841731131362ALPHALOK Plating SystemVILEX LLC2023-08-11
00841731131355ALPHALOK Plating SystemVILEX LLC2023-08-11
00841731131348ALPHALOK Plating SystemVILEX LLC2023-08-11
00841731131331ALPHALOK Plating SystemVILEX LLC2023-08-11

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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