AEQUALIS SHOULDER FRACTURE SYSTEM— 510(k) K032679

Substantially Equivalent

Tornier

FDA 510(k) clearance K032679 for AEQUALIS SHOULDER FRACTURE SYSTEM, Substantially Equivalent on 2003-12-15. Applicant: Tornier.

Clearance details

Applicant: Tornier
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2003-08-29
Decision date: 2003-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Montbonnot, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.