510(k) K233567
K233567 is an FDA 510(k) premarket notification submitted by Flower Orthopedics Corporation Dba Conventus Flower Ortho for the device "OsteoCoil Nitinol Compression System (Multiple Component PNs)". The FDA issued a decision of Substantially Equivalent on November 22, 2024. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2024
- Date Received
- November 6, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type