| Primary Device ID | M555910095510 |
| NIH Device Record Key | 204591cf-2525-4dc8-ad58-2c7f3fe61fd9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Valeo Fusion System |
| Version Model Number | B |
| Catalog Number | 91.009.5510 |
| Company DUNS | 028629553 |
| Company Name | AMEDICA CORPORATION |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com | |
| Phone | 801-839-3500 |
| customerservice@amedica.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M555910095510 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
[M555910095510]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2017-12-29 |
| M555910099021 | Amedica VBR Small Trial Caddy Assembly |
| M555910099011 | Amedica Trial Case, Case Assembly |
| M555910099002 | Valeo VBR Trial Caddy |
| M555910095510 | Valeo Corpectomy Caliper |
| M555110041610 | Valeo PL,9x21, 6°, 10mm |
| M555110041609 | Valeo PL,9x21, 6°, 9mm |
| M555110041608 | Valeo PL,9x21, 6°, 8mm |
| M555110041607 | Valeo PL,9x21, 6°, 7mm |
| M555110041015 | Valeo PL,9x21, 0°, 15mm |
| M555110091630 | Valeo Corpectomy 16x12mm, 6°, 30mm Height |
| M555110091629 | Valeo Corpectomy 16x12mm, 6°, 29mm Height |
| M555110091628 | Valeo Corpectomy 16x12mm, 6°, 28mm Height |
| M555110091627 | Valeo Corpectomy 16x12mm, 6°, 27mm Height |
| M555110091626 | Valeo Corpectomy 16x12mm, 6°, 26mm Height |
| M555110091625 | Valeo Corpectomy 16x12mm, 6°, 25mm Height |
| M555110091624 | Valeo Corpectomy 16x12mm, 6°, 24mm Height |
| M555110091623 | Valeo Corpectomy 16x12mm, 6°, 23mm Height |
| M555110091622 | Valeo Corpectomy 16x12mm, 6°, 22mm Height |
| M555110091621 | Valeo Corpectomy 16x12mm, 6°, 21mm Height |
| M555110091620 | Valeo Corpectomy 16x12mm, 6°, 20mm Height |
| M555110091619 | Valeo Corpectomy 16x12mm, 6°, 19mm Height |
| M555110091618 | Valeo Corpectomy 16x12mm, 6°, 18mm Height |
| M555110091617 | Valeo Corpectomy 16x12mm, 6°, 17mm Height |
| M555110091616 | Valeo Corpectomy 16x12mm, 6°, 16mm Height |
| M555110091615 | Valeo Corpectomy 16x12mm, 6°, 15mm Height |
| M555110091614 | Valeo Corpectomy 16x12mm, 6°, 14mm Height |
| M555110091613 | Valeo Corpectomy 16x12mm, 6°, 13mm Height |
| M555110091030 | Valeo Corpectomy 16x12mm, 0°, 30mm Height |
| M555110091029 | Valeo Corpectomy 16x12mm, 0°, 29mm Height |
| M555110091028 | Valeo Corpectomy 16x12mm, 0°, 28mm Height |
| M555110091027 | Valeo Corpectomy 16x12mm, 0°, 27mm Height |
| M555110091026 | Valeo Corpectomy 16x12mm, 0°, 26mm Height |
| M555110091025 | Valeo Corpectomy 16x12mm, 0°, 25mm Height |
| M555110091024 | Valeo Corpectomy 16x12mm, 0°, 24mm Height |
| M555110091023 | Valeo Corpectomy 16x12mm, 0°, 23mm Height |
| M555110091022 | Valeo Corpectomy 16x12mm, 0°, 22mm Height |
| M555110091021 | Valeo Corpectomy 16x12mm, 0°, 21mm Height |
| M555110091020 | Valeo Corpectomy 16x12mm, 0°, 20mm Height |
| M555110091019 | Valeo Corpectomy 16x12mm, 0°, 19mm Height |
| M555110091018 | Valeo Corpectomy 16x12mm, 0°, 18mm Height |
| M555110091017 | Valeo Corpectomy 16x12mm, 0°, 17mm Height |
| M555110091016 | Valeo Corpectomy 16x12mm, 0°, 16mm Height |
| M555110091015 | Valeo Corpectomy 16x12mm, 0°, 15mm Height |
| M555110091014 | Valeo Corpectomy 16x12mm, 0°, 14mm Height |
| M555110091013 | Valeo Corpectomy 16x12mm, 0°, 13mm Height |