LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331— 510(k) K091453

Name: FDA 510(k) clearance K091453
Creator: U.S. Food and Drug Administration
Published: 2009-08-12

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K091453 for LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331, Substantially Equivalent on 2009-08-12. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 2009-05-18
Decision date: 2009-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.