510(k) K211892
K211892 is an FDA 510(k) premarket notification submitted by Arftx Medical, LLC for the device "ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)". The FDA issued a decision of Substantially Equivalent on October 6, 2022. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2022
- Date Received
- June 21, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Vertebral Body Replacement Device
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type