510(k) K231145
K231145 is an FDA 510(k) premarket notification submitted by Southern Medical (Pty) , Ltd. for the device "Axis Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on June 13, 2023. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Southern Medical (Pty) , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2023
- Date Received
- April 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type