RI.KNEE Adjustable Tibia Cut Guide— 510(k) K230876

Name: FDA 510(k) clearance K230876
Creator: U.S. Food and Drug Administration
Published: 2023-06-27

Substantially Equivalent

Enztec Limited

FDA 510(k) clearance K230876 for RI.KNEE Adjustable Tibia Cut Guide, Substantially Equivalent on 2023-06-27. Applicant: Enztec Limited. Device class: 2.

Clearance details

Applicant: Enztec Limited
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2023-03-30
Decision date: 2023-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleton, NZ

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.