WUJIN #3 TIBIAL NAIL— 510(k) K002325

Clearance details

Applicant

Biologically Oriented Prostheses

Product code

Code JDS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2000-08-01

Decision date

2000-10-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Port Huron, MI, US

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Injury

1,776

Malfunction

1,509

Total

3,285

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 →