K251686

Substantially Equivalent

Tornier Humeral Reconstruction System Max (Tornier HRS Max)

Applicant: Tornier, Inc.
Product code: KWT
Advisory panel: Orthopedic
Date received: 2025-06-02
Decision date: 2025-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.