| Primary Device ID | M555110078535 |
| NIH Device Record Key | 8bac347e-5034-4d52-8da5-e9901eb188bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Valeo Spacer System |
| Version Model Number | C |
| Catalog Number | 11.007.8535 |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 35 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M555110078535 [Primary] |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
[M555110078535]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-11-14 |
| Device Publish Date | 2017-12-29 |
| M555916006713 | Valeo II C, 16x14 6° 13-14mm -0.5 Stop |
| M555916006711 | Valeo II C, 16x14 6° 11-12mm -0.5 Stop |
| M555916006709 | Valeo II C, 16x14 6° 9-10mm -0.5 Stop |
| M555916006707 | Valeo II C, 16x14 6° 7-8mm -0.5 Stop |
| M555916006705 | Valeo II C, 16x14 6° 5-6mm -0.5 Stop |
| M555916006613 | Valeo II C, 14x12 6° 13-14mm -0.5 Stop |
| M555916006611 | Valeo II C, 14x12 6° 11-12mm -0.5 Stop |
| M555916006609 | Valeo II C, 14x12 6° 9-10mm -0.5 Stop |
| M555916006607 | Valeo II C, 14x12 6° 7-8mm -0.5 Stop |
| M555916006605 | Valeo II C, 14x12 6° 5-6mm -0.5 Stop |
| M555916006213 | Valeo II C, 16x14 0° 13-14mm -0.5 Stop |
| M555916006211 | Valeo II C, 16x14 0° 11-12mm -0.5 Stop |
| M555916006209 | Valeo II C, 16x14 0° 9-10mm -0.5 Stop |
| M555916006207 | Valeo II C, 16x14 0° 7-8mm -0.5 Stop |
| M555916006205 | Valeo II C, 16x14 0° 5-6mm -0.5 Stop |
| M555916006113 | Valeo II C, 14x12 0° 13-14mm -0.5 Stop |
| M555916006111 | Valeo II C, 14x12 0° 11-12mm -0.5 Stop |
| M555916006109 | Valeo II C, 14x12 0° 9-10mm -0.5 Stop |
| M555916006107 | Valeo II C, 14x12 0° 7-8mm -0.5 Stop |
| M555916006105 | Valeo II C, 14x12 0° 5-6mm -0.5 Stop |
| M555916005014 | Valeo II Dual Convex Cervical Trial, 14mm |
| M555916005013 | Valeo II Dual Convex Cervical Trial, 13mm |
| M555916005012 | Valeo II Dual Convex Cervical Trial, 12mm |
| M555916005011 | Valeo II Dual Convex Cervical Trial, 11mm |
| M555916005010 | Valeo II Dual Convex Cervical Trial, 10mm |
| M555916005009 | Valeo II Dual Convex Cervical Trial, 9mm |
| M555916005008 | Valeo II Dual Convex Cervical Trial, 8mm |
| M555916005007 | Valeo II Dual Convex Cervical Trial, 7mm |
| M555916005006 | Valeo II Dual Convex Cervical Trial, 6mm |
| M555916004614 | Valeo II 6° 14mm Dual Cervical Trial |
| M555916004613 | Valeo II 6° 13mm Dual Cervical Trial |
| M555916004612 | Valeo II 6° 12mm Dual Cervical Trial |
| M555916004611 | Valeo II 6° 11mm Dual Cervical Trial |
| M555916004610 | Valeo II 6° 10mm Dual Cervical Trial |
| M555916004609 | Valeo II 6° 9mm Dual Cervical Trial |
| M555916004608 | Valeo II 6° 8mm Dual Cervical Trial |
| M555916004607 | Valeo II 6° 7mm Dual Cervical Trial |
| M555916004606 | Valeo II 6° 6mm Dual Cervical Trial |
| M555916004605 | Valeo II 6° 5mm Dual Cervical Trial |
| M555916004014 | Valeo II 0° 14mm Dual Cervical Trial |
| M555916004013 | Valeo II 0° 13mm Dual Cervical Trial |
| M555916004012 | Valeo II 0° 12mm Dual Cervical Trial |
| M555916004011 | Valeo II 0° 11mm Dual Cervical Trial |
| M555916004010 | Valeo II 0° 10mm Dual Cervical Trial |
| M555916004009 | Valeo II 0° 9mm Dual Cervical Trial |
| M555916004008 | Valeo II 0° 8mm Dual Cervical Trial |
| M555916004007 | Valeo II 0° 7mm Dual Cervical Trial |
| M555916004006 | Valeo II 0° 6mm Dual Cervical Trial |
| M555916004005 | Valeo II 0° 5mm Dual Cervical Trial |
| M555916003014 | Valeo II Convex 14mm Dual Cervical Trial |