Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)— 510(k) K231376

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K231376 for Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape), Substantially Equivalent on 2023-08-09. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2023-05-12
Decision date: 2023-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
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.