| Primary Device ID | B07320CFX94070 |
| NIH Device Record Key | 82753913-5c2e-4a24-ae65-9cb7330a168b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | tIwave c caervical Cage System |
| Version Model Number | 20-CFX-9407 |
| Company DUNS | 041956211 |
| Company Name | Kalitec Direct LLC |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B07320CFX94070 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2018-08-31 |
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