510(k) K250602
K250602 is an FDA 510(k) premarket notification submitted by Expanding Innovations, Inc. for the device "X-PAC® N-GAGE Lumbar Plate System". The FDA issued a decision of Substantially Equivalent on May 20, 2025. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Expanding Innovations, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2025
- Date Received
- February 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type