RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS— 510(k) K112897

Name: FDA 510(k) clearance K112897
Creator: U.S. Food and Drug Administration
Published: 2012-06-13

Substantially Equivalent

Renovis Surgical Technologies, LLC

FDA 510(k) clearance K112897 for RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS, Substantially Equivalent on 2012-06-13. Applicant: Renovis Surgical Technologies, LLC. Device class: 2.

Clearance details

Applicant: Renovis Surgical Technologies, LLC
Product code: Code OQG
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2011-10-03
Decision date: 2012-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OQG

product code OQG

Injury: 249
Total: 249

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.