arcad® 2.0 Duo & Quadro osteosynthesis compressive staples— 510(k) K230724

Substantially Equivalent

Novastep

FDA 510(k) clearance K230724 for arcad® 2.0 Duo & Quadro osteosynthesis compressive staples, Substantially Equivalent on 2023-12-04. Applicant: Novastep.

Clearance details

Applicant: Novastep
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2023-03-16
Decision date: 2023-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rennes, FR

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.