Flexible Suturing System with Anchors (FSSA)— 510(k) K222589

Substantially Equivalent

Integrity Orthopaedics, Inc.

FDA 510(k) clearance K222589 for Flexible Suturing System with Anchors (FSSA), Substantially Equivalent on 2023-01-26. Applicant: Integrity Orthopaedics, Inc..

Clearance details

Applicant: Integrity Orthopaedics, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2022-08-26
Decision date: 2023-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Plain, MN, 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.