| Primary Device ID | B07330TTS27070 |
| NIH Device Record Key | d8e272ef-fd7d-493d-a8e1-97bd79767f15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navagio Lumbar Cage |
| Version Model Number | 30-TTS-2707 |
| Catalog Number | 30-TTS-2707 |
| 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 | false |
| 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 | B07330TTS27070 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
[B07330TTS27070]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-20 |
| Device Publish Date | 2024-08-12 |
| B07330TTS27070 | Lumbar Cage, 27x7mm, 14-Degree STR |
| B07330TNS27070 | Lumbar Cage, 27x7mm 0-Degree STR |