A200 KNEE SYSTEM— 510(k) K120038

Substantially Equivalent

Renovis Surgical Technologies, LLC

FDA 510(k) clearance K120038 for A200 KNEE SYSTEM, Substantially Equivalent on 2013-02-14. Applicant: Renovis Surgical Technologies, LLC.

Clearance details

Applicant: Renovis Surgical Technologies, LLC
Product code: Code OIY
Advisory panel: Orthopedic
Date received: 2012-01-05
Decision date: 2013-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code OIY

product code OIY

Injury: 607
Total: 607

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.