510(k) K234031
K234031 is an FDA 510(k) premarket notification submitted by Medline Industires, LP for the device "Medline UNITE Ancillary Foot Recon Plating System". The FDA issued a decision of Substantially Equivalent on January 18, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Medline Industires, LP has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2024
- Date Received
- December 20, 2023
- Clearance Type
- Special
- 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