510(k) K233509
K233509 is an FDA 510(k) premarket notification submitted by Zavation Medical Products, LLC for the device "Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System". The FDA issued a decision of Substantially Equivalent on Apr 10, 2024. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Zavation Medical Products, LLC has 30 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 10, 2024
- Date Received
- Oct 31, 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
- 510(k)
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.