AEQUALIS FLEX REVIVE Shoulder System— 510(k) K191318

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K191318 for AEQUALIS FLEX REVIVE Shoulder System, Substantially Equivalent on 2019-06-14. Applicant: Tornier, Inc..

Clearance details

Applicant: Tornier, Inc.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2019-05-15
Decision date: 2019-06-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, MN, US

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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.