The following data is part of a premarket notification filed by Difusion Technologies with the FDA for Xihpos™ Zfuze™ Interbody Fusion System.
| Device ID | K190544 |
| 510k Number | K190544 |
| Device Name: | XIHPOS™ ZFUZE™ Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | DiFusion Technologies 1624 Headway Circle Austin, TX 78754 |
| Contact | Derrick Johns |
| Correspondent | John J. Smith Hogan Lovells 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853896008007 | K190544 | 000 |
| 00853896008120 | K190544 | 000 |
| 00853896008137 | K190544 | 000 |
| 00853896008144 | K190544 | 000 |
| 00853896008151 | K190544 | 000 |
| 00853896008168 | K190544 | 000 |
| 00853896008175 | K190544 | 000 |
| 00853896008199 | K190544 | 000 |
| 00853896008205 | K190544 | 000 |
| 00853896008113 | K190544 | 000 |
| 00853896008106 | K190544 | 000 |
| 00853896008090 | K190544 | 000 |
| 00853896008014 | K190544 | 000 |
| 00853896008021 | K190544 | 000 |
| 00853896008038 | K190544 | 000 |
| 00853896008045 | K190544 | 000 |
| 00853896008052 | K190544 | 000 |
| 00853896008069 | K190544 | 000 |
| 00853896008076 | K190544 | 000 |
| 00853896008083 | K190544 | 000 |
| 00853896008212 | K190544 | 000 |
| 00853896008229 | K190544 | 000 |
| 00853896008342 | K190544 | 000 |
| 00853896008359 | K190544 | 000 |
| 00853896008366 | K190544 | 000 |
| 00853896008373 | K190544 | 000 |
| 00853896008380 | K190544 | 000 |
| 00853896008397 | K190544 | 000 |
| 00853896008403 | K190544 | 000 |
| 00853896008410 | K190544 | 000 |
| 00853896008335 | K190544 | 000 |
| 00853896008328 | K190544 | 000 |
| 00853896008311 | K190544 | 000 |
| 00853896008236 | K190544 | 000 |
| 00853896008243 | K190544 | 000 |
| 00853896008250 | K190544 | 000 |
| 00853896008267 | K190544 | 000 |
| 00853896008274 | K190544 | 000 |
| 00853896008281 | K190544 | 000 |
| 00853896008298 | K190544 | 000 |
| 00853896008304 | K190544 | 000 |
| 00853896008182 | K190544 | 000 |