Newclip Patient-matched instrumentation non sterile PSI— 510(k) K243912

Substantially Equivalent

Newclip Technics

FDA 510(k) clearance K243912 for Newclip Patient-matched instrumentation non sterile PSI, Substantially Equivalent on 2025-02-13. Applicant: Newclip Technics.

Clearance details

Applicant: Newclip Technics
Product code: Code PBF
Advisory panel: Orthopedic
Date received: 2024-12-19
Decision date: 2025-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haute Goulaine, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code PBF

product code PBF

Injury: 180
Total: 180

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.