METAL HEMI IMPLANT— 510(k) K071243

Substantially Equivalent

Orthopro, LLC

FDA 510(k) clearance K071243 for METAL HEMI IMPLANT, Substantially Equivalent on 2007-05-23. Applicant: Orthopro, LLC.

Clearance details

Applicant: Orthopro, LLC
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2007-05-03
Decision date: 2007-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

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.