Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis— 510(k) K151293

Substantially Equivalent

Tornier S.A.S.

FDA 510(k) clearance K151293 for Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis, Substantially Equivalent on 2015-09-24. Applicant: Tornier S.A.S..

Clearance details

Applicant: Tornier S.A.S.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2015-05-15
Decision date: 2015-09-24
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.