510(k) K240321
K240321 is an FDA 510(k) premarket notification submitted by Hager& Meisinger GmbH for the device "MP Pin flat without thread (36BMP000020/MP20)". The FDA issued a decision of Substantially Equivalent on October 17, 2024. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Hager& Meisinger GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2024
- Date Received
- February 2, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type