Primary Device ID | B07330TNS27070 |
NIH Device Record Key | 6f886a07-3fd6-4035-a876-f00b08b7f55e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Navagio Lumbar Cage |
Version Model Number | 30-TNS-2707 |
Catalog Number | 30-TNS-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 | B07330TNS27070 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
Moist Heat or Steam Sterilization
[B07330TNS27070]
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 |