510(k) K221615— Newclip Patient-matched instrumentation non sterile PSI

Substantially Equivalent

Newclip Technics

Clearance details

Applicant: Newclip Technics
Product code: Code PBF
Advisory panel: Orthopedic
Date received: 2022-06-03
Decision date: 2023-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haute-Goulaine, FR

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.