FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL— 510(k) K123579

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K123579 for FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL, Substantially Equivalent on 2013-01-23. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2012-11-19
Decision date: 2013-01-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.