SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE— 510(k) K110069

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K110069 for SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE, Substantially Equivalent on 2011-02-08. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2011-01-10
Decision date: 2011-02-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.