GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)— 510(k) K142072

Substantially Equivalent

Custom Orthopaedic Solutions, Inc.

FDA 510(k) clearance K142072 for GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS), Substantially Equivalent on 2014-11-24. Applicant: Custom Orthopaedic Solutions, Inc..

Clearance details

Applicant: Custom Orthopaedic Solutions, Inc.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2014-07-23
Decision date: 2014-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, 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.