StarFuse Interphalangeal Pin— 510(k) K160194

Substantially Equivalent

Phalanx Innovations

FDA 510(k) clearance K160194 for StarFuse Interphalangeal Pin, Substantially Equivalent on 2016-04-26. Applicant: Phalanx Innovations.

Clearance details

Applicant: Phalanx Innovations
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2016-01-27
Decision date: 2016-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, 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.