The following data is part of a premarket notification filed by Expanding Innovations, Inc with the FDA for X-pac Expandable Lumbar Cage System.
| Device ID | K222797 |
| 510k Number | K222797 |
| Device Name: | X-Pac Expandable Lumbar Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Expanding Innovations, Inc 110 Pioneer Way, Ste 1 Mountain View, CA 94041 -1519 |
| Contact | Robert Jaramillo |
| Correspondent | Carolyn Guthrie Kapstone Medical, LLC 510 Elliot Street Charlotte, NC 28202 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-16 |
| Decision Date | 2022-10-14 |