FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET— 510(k) K133930

Substantially Equivalent

Flower Orthopedics Corporation

FDA 510(k) clearance K133930 for FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET, Substantially Equivalent on 2014-03-27. Applicant: Flower Orthopedics Corporation.

Clearance details

Applicant: Flower Orthopedics Corporation
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2013-12-23
Decision date: 2014-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsham, PA, 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.