Shotel Ankle Arthrodesis Nail System— 510(k) K163627

Substantially Equivalent

Biopro, Inc.

FDA 510(k) clearance K163627 for Shotel Ankle Arthrodesis Nail System, Substantially Equivalent on 2017-09-14. Applicant: Biopro, Inc..

Clearance details

Applicant: Biopro, Inc.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2016-12-22
Decision date: 2017-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

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Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.