510(k) K243915
K243915 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "FIX-C 3D Ti ACIF System". The FDA issued a decision of Substantially Equivalent on February 18, 2025. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Jeil Medical Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2025
- Date Received
- December 20, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Bone Graft, Cervical
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.