Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate— 510(k) K213489

Substantially Equivalent

Wishbone Medical, Inc.

FDA 510(k) clearance K213489 for Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate, Substantially Equivalent on 2022-01-27. Applicant: Wishbone Medical, Inc..

Clearance details

Applicant: Wishbone Medical, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2021-11-01
Decision date: 2022-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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.