510(k) K230872
K230872 is an FDA 510(k) premarket notification submitted by Shanghai Sanyou Medical Co, Ltd. for the device "Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System". The FDA issued a decision of Substantially Equivalent on December 12, 2023. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Shanghai Sanyou Medical Co, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2023
- Date Received
- March 30, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.