510(k) K261968— Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)

Substantially Equivalent

Smith & Nephew, Inc.

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2026-06-11
Decision date: 2026-07-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

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.