1.5MM BONE FIXATION KIT— 510(k) K012000

Substantially Equivalent

Bionx Implants, Ltd.

FDA 510(k) clearance K012000 for 1.5MM BONE FIXATION KIT, Substantially Equivalent on 2001-07-18. Applicant: Bionx Implants, Ltd..

Clearance details

Applicant: Bionx Implants, Ltd.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2001-06-27
Decision date: 2001-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampere, FI

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.