510(k) K262126
K262126 is an FDA 510(k) premarket notification submitted by MK Medical GmbH for the device "Cerclage Wires;K-wires;Steinmann Pins". The FDA issued a decision of Substantially Equivalent on Oct 22, 2026. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 22, 2026
- Date Received
- Jun 24, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)