| Primary Device ID | B030CK2412090 |
| NIH Device Record Key | 6dee2873-4ade-44e2-93c5-cad8880318ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TLS 5.0 |
| Version Model Number | CK-241209 |
| Company DUNS | 054205979 |
| Company Name | CAMBER SPINE TECHNOLOGIES, 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 | true |
| 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 |
| Phone | 1-866-643-0739 |
| customerservice@cambermedtech.com | |
| Phone | 1-866-643-0739 |
| customerservice@cambermedtech.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B030CK2412090 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B030CK2412090]
Moist Heat or Steam Sterilization
[B030CK2412090]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-10-27 |
| B030CX3010150 | Interbody Fusion Device 7DEG x30L x 10W x15H |
| B030CX3010140 | Interbody Fusion Device 7DEG x30L x 10W x14H |
| B030CX3010130 | Interbody Fusion Device 7DEG x30L x 10W x13H |
| B030CX3010120 | Interbody Fusion Device 7DEG x30L x 10W x12H |
| B030CX3010110 | Interbody Fusion Device 7DEG x30L x 10W x11H |
| B030CX3010100 | Interbody Fusion Device 7DEG x30L x 10W x10H |
| B030CX3010090 | Interbody Fusion Device 7DEG x30L x 10W x9H |
| B030CX3010080 | Interbody Fusion Device 7DEG x30L x 10W x8H |
| B030CX3010070 | Interbody Fusion Device 7DEG x30L x 10W x7H |
| B030CX2610150 | Interbody Fusion Device 7DEG x 26L x 10W x 15H |
| B030CX2610140 | Interbody Fusion Device 7DEG x 26L x 10W x 14H |
| B030CX2610130 | Interbody Fusion Device 7DEG x 26L x 10W x 13H |
| B030CX2610120 | Interbody Fusion Device 7DEG x 26L x 10W x 12H |
| B030CX2610110 | Interbody Fusion Device 7DEG x 26L x 10W x 11H |
| B030CX2610100 | Interbody Fusion Device 7DEG x 26L x 10W x 10H |
| B030CX2610090 | Interbody Fusion Device 7DEG x 26L x 10W x 9H |
| B030CX2610080 | Interbody Fusion Device 7DEG x 26L x 10W x 8H |
| B030CX2610070 | Interbody Fusion Device 7DEG x 26L x 10W x 7H |
| B030CX2210150 | Interbody Fusion Device 7DEG x 22L x 10W x 15H |
| B030CX2210140 | Interbody Fusion Device 7DEG x 22L x 10W x 14H |
| B030CX2210130 | Interbody Fusion Device 7DEG x 22L x 10W x 13H |
| B030CX2210120 | Interbody Fusion Device 7DEG x 22L x 10W x 12H |
| B030CX2210110 | Interbody Fusion Device 7DEG x 22L x 10W x 11H |
| B030CX2210100 | Interbody Fusion Device 7DEG x 22L x 10W x 10H |
| B030CX2210090 | Interbody Fusion Device 7DEG x 22L x 10W x 9H |
| B030CX2210080 | Interbody Fusion Device 7DEG x 22L x 10W x 8H |
| B030CX2210070 | Interbody Fusion Device 7DEG x 22L x 10W x 7H |
| B030CK2810150 | Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 15H |
| B030CK2810140 | Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 14H |
| B030CK2810130 | Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 13H |
| B030CK2810120 | Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 12H |
| B030CK2810110 | Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 11H |
| B030CK2810100 | Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 10H |
| B030CK2810090 | Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 9H |
| B030CK2810080 | Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 8H |
| B030CK2810070 | Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 7H |
| B030CK2412150 | Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 15H |
| B030CK2412140 | Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 14H |
| B030CK2412130 | Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 13H |
| B030CK2412120 | Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 12H |
| B030CK2412110 | Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 11H |
| B030CK2412100 | Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 10H |
| B030CK2412090 | Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 9H |
| B030CK2412080 | Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 8H |
| B030CK2412070 | Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 7H |
| B030CK2212150 | Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 15H |
| B030CK2212140 | Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 14H |
| B030CK2212130 | Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 13H |
| B030CK2212120 | Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 12H |
| B030CK2212110 | Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 11H |