CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System— 510(k) K193543

Substantially Equivalent

In2bones USA, LLC

FDA 510(k) clearance K193543 for CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System, Substantially Equivalent on 2020-01-17. Applicant: In2bones USA, LLC.

Clearance details

Applicant: In2bones USA, LLC
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2019-12-20
Decision date: 2020-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, 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.