510(k) K253373
K253373 is an FDA 510(k) premarket notification submitted by Southern Medical (Pty) , Ltd. for the device "Southern Craniomaxillofacial (CMF) System". The FDA issued a decision of Substantially Equivalent on December 19, 2025. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Southern Medical (Pty) , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2025
- Date Received
- September 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type