| Primary Device ID | B707125342180 |
| NIH Device Record Key | 9ce57288-b945-4bc1-92b3-2085a54c63c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUALX ACME PIN |
| Version Model Number | 12534218 |
| Company DUNS | 081021000 |
| Company Name | Amplify Surgical, 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B707125342180 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
[B707125342180]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-09-11 |
| Device Publish Date | 2021-09-01 |
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| B707128300090010 - DUALX LLIF LOCKOUT SCREW 2 X 40MM | 2025-05-08 DUALX LLIF LOCKOUT SCREW 2 X 40MM |