The following data is part of a premarket notification filed by Difusion Technologies with the FDA for Difusion Technologies Xiphos Interbody Fusion System.
| Device ID | K100042 |
| 510k Number | K100042 |
| Device Name: | DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | DIFUSION TECHNOLOGIES 701 BRAZOS STREET SUITE 500 Austin, TX 78701 |
| Contact | Jami Hafiz |
| Correspondent | Jami Hafiz DIFUSION TECHNOLOGIES 701 BRAZOS STREET SUITE 500 Austin, TX 78701 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-08 |
| Decision Date | 2010-10-01 |
| Summary: | summary |