BIOPRO HEMI-EDGE TOE SYSTEM— 510(k) K121973

Name: FDA 510(k) clearance K121973
Creator: U.S. Food and Drug Administration
Published: 2012-10-30

Substantially Equivalent

Biopro, Inc.

FDA 510(k) clearance K121973 for BIOPRO HEMI-EDGE TOE SYSTEM, Substantially Equivalent on 2012-10-30. Applicant: Biopro, Inc.. Device class: 2.

Clearance details

Applicant: Biopro, Inc.
Product code: Code KWD
Device class: Class 2
Regulation: 21 CFR 888.3730
Advisory panel: Orthopedic
Date received: 2012-07-05
Decision date: 2012-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prior Lake, MN, US

Download summary PDF View on FDA.gov ↗

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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.