510(k) K251620
K251620 is an FDA 510(k) premarket notification submitted by Zimmer Biomet for the device "A.L.P.S. Proximal Humerus Plating System". The FDA issued a decision of Substantially Equivalent on July 25, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Zimmer Biomet has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2025
- Date Received
- May 27, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type