DePuy Synthes Hammertoe Continuous Compression Implant— 510(k) K191463

Substantially Equivalent

Synthes (USA) Products, LLC

FDA 510(k) clearance K191463 for DePuy Synthes Hammertoe Continuous Compression Implant, Substantially Equivalent on 2020-02-26. Applicant: Synthes (USA) Products, LLC.

Clearance details

Applicant: Synthes (USA) Products, LLC
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2019-06-03
Decision date: 2020-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.