K233105

Substantially Equivalent

RESPONSE Rib and Pelvic System

Applicant: OrthoPediatrics Corp.
Product code: MDI
Advisory panel: Orthopedic
Date received: 2023-09-27
Decision date: 2024-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Adverse events under product code MDI

product code MDI

Injury: 133
Total: 133

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.