Argulated Locking Plates— 510(k) K143338

Clearance details

Applicant

Osteomed LP

Product code

Code JEY

Device class

Class 2

Regulation

21 CFR 872.4760

Advisory panel

Dental

Date received

2014-11-20

Decision date

2015-04-01

Decision

Substantially Equivalent

Clearance type

Special

Location

Addison, TX, US

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Injury

1,542

Malfunction

2,292

Total

3,834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →