| Primary Device ID | 00853896008328 |
| NIH Device Record Key | e7c798ca-044f-4e08-bd27-2f4bcdeb51f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XIPHOS ZFUZE |
| Version Model Number | ZF-300-3011 |
| Catalog Number | ZF-300-3011 |
| Company DUNS | 022051967 |
| Company Name | Difusion Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 512-284-4440 |
| customerservice@difusiontech.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853896008328 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-02 |
| Device Publish Date | 2020-02-21 |
| 00853896008007 - XIPHOS ZFUZE | 2020-03-02 PLIF Spacer 22mm Long x 11mm Height |
| 00853896008014 - XIPHOS ZFUZE | 2020-03-02 PLIF Spacer 22mm Long x 8mm Height |
| 00853896008021 - XIPHOS ZFUZE | 2020-03-02 PLIF Spacer 22mm Long x 9mm Height |
| 00853896008038 - XIPHOS ZFUZE | 2020-03-02 PLIF Spacer 22mm Long x 10mm Height |
| 00853896008045 - XIPHOS ZFUZE | 2020-03-02 PLIF Spacer 22mm Long x 12mm Height |
| 00853896008052 - XIPHOS ZFUZE | 2020-03-02 PLIF Spacer 22mm Long x 13mm Height |
| 00853896008069 - XIPHOS ZFUZE | 2020-03-02 PLIF Spacer 22mm Long x 14mm Height |
| 00853896008076 - XIPHOS ZFUZE | 2020-03-02 PLIF Spacer 26mm Long x 8mm Height |