Suture Button Repair System— 510(k) K240835

Substantially Equivalent

Skeletal Dynamics, Inc.

FDA 510(k) clearance K240835 for Suture Button Repair System, Substantially Equivalent on 2024-07-19. Applicant: Skeletal Dynamics, Inc..

Clearance details

Applicant: Skeletal Dynamics, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2024-03-26
Decision date: 2024-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.