DRIM-Nail System— 510(k) K260115
Substantially Equivalent41Medical AG
FDA 510(k) clearance K260115 for DRIM-Nail System, Substantially Equivalent on 2026-09-11. Applicant: 41Medical AG.
Summary
The DRIM-Nail System from 41Medical comes with thin record data. There's no product code, and the advisory panel field reads Unknown. In orthopedics a "nail system" is usually intramedullary fixation for long-bone fractures, but nothing in the record confirms that. Without a product code, the class and regulation can't be filled in either.
It was a Traditional 510(k), decided Substantially Equivalent.
41Medical is based in Bettlach, Switzerland. Review took 240 days (January 14 to September 11, 2026). Recent openFDA records sometimes pick up missing product codes later, so this page may fill out on a future refresh.
Clearance details
- Applicant
- 41Medical AG
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bettlach, CH
Data sourced from openFDA. This site is unofficial and independent of the FDA.