510(k) K231819
K231819 is an FDA 510(k) premarket notification submitted by Innovate Orthopaedics Limited for the device "Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw". The FDA issued a decision of Substantially Equivalent on September 5, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Innovate Orthopaedics Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2023
- Date Received
- June 21, 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