AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL— 510(k) K133668

Substantially Equivalent

Shoulder Options, Inc.

FDA 510(k) clearance K133668 for AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL, Substantially Equivalent on 2014-03-03. Applicant: Shoulder Options, Inc..

Clearance details

Applicant: Shoulder Options, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2013-11-29
Decision date: 2014-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waxhaw, NC, 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.