Q-FIX ULTRA All-Suture Anchor— 510(k) K232457

Substantially Equivalent

Smith & Nephew

FDA 510(k) clearance K232457 for Q-FIX ULTRA All-Suture Anchor, Substantially Equivalent on 2023-09-08. Applicant: Smith & Nephew.

Clearance details

Applicant: Smith & Nephew
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2023-08-14
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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.