Hammerdesis Interphalangeal Fusion System— 510(k) K231147

Substantially Equivalent

Intelivation

FDA 510(k) clearance K231147 for Hammerdesis Interphalangeal Fusion System, Substantially Equivalent on 2023-09-14. Applicant: Intelivation.

Clearance details

Applicant: Intelivation
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2023-04-21
Decision date: 2023-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth Meeting, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.