510(k) K201336— DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm

Substantially Equivalent

Synthes (USA) Products, LLC

Clearance details

Applicant: Synthes (USA) Products, LLC
Product code: Code JDS
Advisory panel: Orthopedic
Date received: 2020-05-20
Decision date: 2020-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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.