SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT— 510(k) K122623

Substantially Equivalent

Advanced Orthopaedic Solutions, Inc.

FDA 510(k) clearance K122623 for SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT, Substantially Equivalent on 2012-09-26. Applicant: Advanced Orthopaedic Solutions, Inc..

Clearance details

Applicant: Advanced Orthopaedic Solutions, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2012-08-28
Decision date: 2012-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Torrance, CA, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.