Aequalis Ascend Flex Shoulder System— 510(k) K190521

Substantially Equivalent

Tornier S.A.S.

FDA 510(k) clearance K190521 for Aequalis Ascend Flex Shoulder System, Substantially Equivalent on 2019-06-12. Applicant: Tornier S.A.S..

Clearance details

Applicant: Tornier S.A.S.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2019-03-04
Decision date: 2019-06-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Monbonnot Saint Martin, 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.