510(k) K250603
K250603 is an FDA 510(k) premarket notification submitted by Innovasis for the device "AxTiHA® Stand-Alone ALIF System". The FDA issued a decision of Substantially Equivalent on March 24, 2025. The device falls under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar), a Class II device regulated under 21 CFR 888.3080. Innovasis has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2025
- Date Received
- February 28, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.