| Primary Device ID | 00190776386757 |
| NIH Device Record Key | b41674f2-797f-4c79-bbad-95e983e894ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONDUIT SYNFIX Evolution |
| Version Model Number | 440225170 |
| Company DUNS | 792528510 |
| Company Name | Avalign 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 | false |
| 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 | +18772891096 |
| product.questions@avalign.com | |
| Phone | +18772891096 |
| product.questions@avalign.com | |
| Phone | +18772891096 |
| product.questions@avalign.com | |
| Phone | +18772891096 |
| product.questions@avalign.com | |
| Phone | +18772891096 |
| product.questions@avalign.com | |
| Phone | +18772891096 |
| product.questions@avalign.com | |
| Phone | +18772891096 |
| product.questions@avalign.com | |
| Phone | +18772891096 |
| product.questions@avalign.com | |
| Phone | +18772891096 |
| product.questions@avalign.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190776386757 [Primary] |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190776386757]
Moist Heat or Steam Sterilization
[00190776386757]
Moist Heat or Steam Sterilization
[00190776386757]
Moist Heat or Steam Sterilization
[00190776386757]
Moist Heat or Steam Sterilization
[00190776386757]
Moist Heat or Steam Sterilization
[00190776386757]
Moist Heat or Steam Sterilization
[00190776386757]
Moist Heat or Steam Sterilization
[00190776386757]
Moist Heat or Steam Sterilization
[00190776386757]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-14 |
| Device Publish Date | 2025-08-06 |
| 00190776386832 | Trial Caddy |
| 00190776386825 | Locking Key |
| 00190776386801 | Trial AH 19mm 25DEG L |
| 00190776386788 | Trial AH 19mm 30DEG M |
| 00190776386764 | Trial AH 19mm 25DEG M |
| 00190776386757 | Trial AH 17mm 25DEG M |
| 00190776386733 | Trial AH 19mm 30DEG S |
| 00190776386702 | Trial AH 19mm 25DEG S |
| 00190776386696 | Trial AH 17mm 25DEG S |
| 00190776386689 | Trial AH 15mm 25DEG S |
| 00190776386597 | Cage AH 19mm 25DEG L |
| 00190776386573 | Cage AH 19mm 30DEG M |
| 00190776386559 | Cage AH 19mm 25DEG M |
| 00190776386542 | Cage AH 17mm 25DEG M |
| 00190776386528 | Cage AH 19mm 30DEG S |
| 00190776386498 | Cage AH 19mm 25DEG S |
| 00190776386481 | Cage AH 17mm 25DEG S |
| 00190776386474 | Cage AH 15mm 25DEG S |