WUJIN #3 TIBIAL NAIL— 510(k) K002325

Substantially Equivalent

Biologically Oriented Prostheses

FDA 510(k) clearance K002325 for WUJIN #3 TIBIAL NAIL, Substantially Equivalent on 2000-10-30. Applicant: Biologically Oriented Prostheses.

Clearance details

Applicant: Biologically Oriented Prostheses
Product code: Code JDS
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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Adverse events under product code JDS

product code JDS

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.