STRYKER ALL SUTURE ANCHORS— 510(k) K120509

Substantially Equivalent

Stryker

FDA 510(k) clearance K120509 for STRYKER ALL SUTURE ANCHORS, Substantially Equivalent on 2012-07-26. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2012-02-21
Decision date: 2012-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, 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.