TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870— 510(k) K041595

Substantially Equivalent

Biopro, Inc.

FDA 510(k) clearance K041595 for TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870, Substantially Equivalent on 2004-11-12. Applicant: Biopro, Inc..

Clearance details

Applicant: Biopro, Inc.
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2004-06-14
Decision date: 2004-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

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Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.