510(k) K222028
K222028 is an FDA 510(k) premarket notification submitted by Alphatec Spine for the device "IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System". The FDA issued a decision of Substantially Equivalent on Oct 7, 2022. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Alphatec Spine has 100 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 7, 2022
- Date Received
- Jul 11, 2022
- 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.