SMITH & NEPHEW RJ CONSTRAINED LINERS— 510(k) K111635

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K111635 for SMITH & NEPHEW RJ CONSTRAINED LINERS, Substantially Equivalent on 2011-09-09. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code KWZ
Advisory panel: Orthopedic
Date received: 2011-06-13
Decision date: 2011-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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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.