| Primary Device ID | B043AV6152500 |
| NIH Device Record Key | 8dec678c-b7ac-4084-936f-3ff463cf3321 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Express IBFD |
| Version Model Number | AV6_15250 |
| Company DUNS | 016610358 |
| Company Name | Advanced Vertebral Solutions, 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B043AV6152500 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B043AV6152500]
Moist Heat or Steam Sterilization
[B043AV6152500]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2015-10-22 |
| B043AV6173000 | AV6_17300 |
| B043AV6172500 | AV6_17250 |
| B043AV6153000 | AV6_15300 |
| B043AV6152500 | AV6_15250 |
| B043AV6133000 | AV6_13300 |
| B043AV6132500 | AV6_13250 |
| B043AV6123000 | AV6_12300 |
| B043AV6122500 | AV6_12250 |
| B043AV6113000 | AV6_11300 |
| B043AV6112500 | AV6_11250 |
| B043AV6103000 | AV6_10300 |
| B043AV6102500 | AV6_10250 |
| B043AV6093000 | AV6_09300 |
| B043AV6092500 | AV6_09250 |
| B043AV6083000 | AV6_08300 |
| B043AV6082500 | AV6_08250 |
| B043AV4TI17250C0 | AV4-Ti_17250C |
| B043AV4TI15250C0 | AV4-Ti_15250C |
| B043AV4TI13250C0 | AV4-Ti_13250C |
| B043AV4TI12250C0 | AV4-Ti_12250C |
| B043AV4TI11250C0 | AV4-Ti_11250C |
| B043AV4TI10250C0 | AV4-Ti_10250C |
| B043AV4TI09250C0 | AV4-Ti_09250C |
| B043AV4TI08250C0 | AV4-Ti_08250C |
| B043AV417250C0 | AV4_17250C |
| B043AV415250C0 | AV4_15250C |
| B043AV413250C0 | AV4_13250C |
| B043AV412250C0 | AV4_12250C |
| B043AV411250C0 | AV4_11250C |
| B043AV410250C0 | AV4_10250C |
| B043AV409250C0 | AV4_09250C |
| B043AV408250C0 | AV4_08250C |