| Primary Device ID | B70712531006005B0 |
| NIH Device Record Key | 7f1b5cd8-0470-463d-a381-b668b91ec8c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUALX TLIF 8 DEG x 9-12MM |
| Version Model Number | 12531006005B |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 949-220-1286 |
| admin@innovasiveinc.com | |
| Phone | 949-220-1286 |
| admin@innovasiveinc.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B70712531006005B0 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-05-13 |
| Device Publish Date | 2019-01-09 |
| B70712531006005B0 | TLIF IMPLANT - Revision B Lordosis & Heights: 8° x 9-12mm Lateral Length/Width: 21.1 mm Superio |
| B70712531006005A0 | TLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Lateral Length/Width: 21.1 mm Superior - Inferior |
| B707125310060050 | TLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Collapsed Width (mm): 12.32 Expanded Width (mm): |
| B707125310060040 | PLEASE DELETE |