SURESHOT Distal Targeting System V4.0 Trauma Interface— 510(k) K170977

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K170977 for SURESHOT Distal Targeting System V4.0 Trauma Interface, Substantially Equivalent on 2017-05-03. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2017-04-03
Decision date: 2017-05-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

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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.