510(k) K243888
K243888 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "Medline UNITE® REFLEX® Hybrid Nitinol Implant System". The FDA issued a decision of Substantially Equivalent on April 11, 2025. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Medline Industries, LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2025
- Date Received
- December 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type