SMITH & NEPHEW R3 CONSTRAINED LINERS— 510(k) K122139

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K122139 for SMITH & NEPHEW R3 CONSTRAINED LINERS, Substantially Equivalent on 2012-10-16. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code KWZ
Advisory panel: Orthopedic
Date received: 2012-07-19
Decision date: 2012-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWZ

product code KWZ

Injury: 993
Total: 993

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.